FCC ID: VPP1200WR WIRELESS ECG RECORDING SYSTEM

0473 Instructions for Use and Technical Description ii Instructions for Use and Technical Description Norav Users Guide For Models: 1200W recorder; software versions: 5.0 and later Copyright Norav, March 08. All rights reserved. Document Number: NV-54/PCECG1200W No part of this publication may be reproduced in any material form (including photocopying or storing it in any medium by electronic means whether or not transiently or incidentally to some other use of this publication) without the prior written permission of the copyright owner, or under the terms of a license issued by the copyright owner. The information contained in this document is subject to change without notice. Norav is neither responsible for nor liable to anyone in connection with this document. Contact Information:

Norav Medical 2, Hamada St., P.O. Box 81, Yokneam, 20692, Israel Telephone:

+972 (04) 9893001 Fax:

Email:

+972 (04) 9893004 sales@norav.com Standards Compliance The interference generated by the device was tested according to the EMC 89/336/EEC and found compliant with the standard. The software complies with Standards for Analysis of Ventricular Late Potentials Using High Resolution or Signal Averaged Electrocardiography, published in 1991 by the Task Force Committee of the European Society of Cardiology, the American Heart Association, and the American College of Cardiology. The PC-ECG conforms to MDD 93/42 EEC Annex II, EC11 and EN 60601-2. MDD authorized representative in Europe is:

Daniele Marangoni Dr. Eng. , Marangoni Consultants Vicolo S. Franc. al Corso 4 Ang. Pontiere 11 37122 Verona Italy phone +39 045 8030516, fax +39 045 8036028 mobile +39 335 290679, Email marangon@easynet.it

Ca u t io n US Federal Law restricts this device to sale by, or on the order of, a physician iii The PC-ECG 1200W is tested and certified for the following standards:

EN60601/1:

EN60601/2/25:

EN60601/2/27:

EN301 489-1;

EN301 489-3;

EN300 440;

International International International International International International Protection type and class:

CF Defibrillation protection:

Built in Disclaimer This system is intended as a decision support system for persons who have received appropriate medical training, and should not be used as a sole basis for making clinical decisions pertaining to patient diagnosis, care, or management. Any application of medical information from the program, other than the original design or intended use thereof, is not advised and considered a misuse of the software product. Norav Limited Warranty Norav products are warranted to be free from manufacturing and material defects for a period of one (1) year from the date of shipment from Norav or the dealer to the original purchaser. Excluded from this warranty are expendable supply items including, but not limited to, electrodes, lead wires, patient cables, and batteries. This warranty does not apply to any product that Norav determines has been modified or damaged by the customer. Except for the express warranties stated above, Norav disclaims all warranties including implied warranties of merchantability and fitness. The stated express warranties are in lieu of all obligations or liabilities on the part of Norav for damages, including but not limited to, special, indirect, or consequential, arising out of or in connection with the use or performance of Norav products. Any action for breach of warranty shall be commenced within one (1) year of said breach or be forever barred. Any repairs made to the product that are not covered by the warranty shall be billed to the customer. For service or technical support contact your local supplier or Norav Medical. v Table of Contents CHAPTER 1:

INTRODUCTION.......................................................................... 1 MANUAL ORGANIZATION...........................................................................................................1 DOCUMENT CONVENTIONS .......................................................................................................1 Notes and Cautions .....................................................................................................................1 Abbreviations and Acronyms .......................................................................................................2 Equipment Symbols .....................................................................................................................2 CHAPTER 2: OVERVIEW .................................................................................... 3 PACKAGE CONTENTS ..................................................................................................................3 PROGRAMS.....................................................................................................................................4 PC-ECG MODELS........................................................................................................................4 INDICATIONS FOR USE OF THE PC-ECG 1200........................................................................5 ECG Intended Use......................................................................................................................5 Stress Testing Intended Use ..........................................................................................................5 CONTRAINDICATIONS FOR USE AND ADVERSE EFFECTS ......................................................6 CHAPTER 3: SOFTWARE INSTALLATION ..................................................... 7 SYSTEM REQUIREMENTS AND PREREQUISITES........................................................................7 Hardware ....................................................................................................................................7 INSTALLING OR UPDATING THE PC SOFTWARE .....................................................................8 To Install PC-ECG 1200 ..........................................................................................................9 To Uninstall PC-ECG 1200....................................................................................................10 To Free Disk Space and Ensure Smooth Operation ...................................................................10 BACKING UP AND RESTORING SETUPS AND PROTOCOLS ....................................................10 To Save Stress Test Setup ..........................................................................................................11 To Load Stress Test Setup .........................................................................................................11 To Save Stress Protocols .............................................................................................................11 To Load Stress Protocols ............................................................................................................12 To Set Preferences.......................................................................................................................12 CHAPTER 4: HARDWARE INSTALLATION .................................................. 13 SAFETY.........................................................................................................................................13 CLASSIFICATION OF THE EQUIPMENT ........................................................ 14 INSTALLING MODEL 1200W.....................................................................................................15 To Connect Via USB................................................................................................................17 To Verify the Connections ..........................................................................................................18 To Perform Maintenance ............................................................................................................18 Calibration ................................................................................................................................19 CONNECTING AN EXERCISE DEVICE......................................................................................19 To Connect an RS232 Controlled Treadmill/Ergometer ............................................................19 vi Instructions for Use and Technical Description To Connect an Analog Controlled Treadmill/Ergometer............................................................ 19 Cabling ..................................................................................................................................... 19 To Determine Treadmill Cabling ............................................................................................... 19 CONNECTING A BLOOD PRESSURE STRESS MONITOR......................................................... 20 To Connect a Blood Pressure stress Monitor ............................................................................... 20 CHAPTER 5: ACCESSORIES INSTALLATION ...............................................21 D/A BOARD: MODEL: CIO-DAC02 FOR ISA BUS............................................................... 21 Jumpers Setting.......................................................................................................................... 21 Settings and Output of the D/A Board for 0-4 Volt Output .................................................... 21 Settings and Output of the D/A Board for -4 to +4 Volt Output ............................................ 22 To Continue Setup (After Installing the ISA Board/s).............................................................. 22 PCI BUS BOARD FUNCTIONING AS AN ECG TRIGGER ....................................................... 23 To Set Up an ECG Trigger via PCI Bus Board ....................................................................... 23 To Complete Setup .................................................................................................................... 23 Cable for PCI board.................................................................................................................. 23 INSTALLATION OF THE TANGO AUTOMATIC BP UNIT..................................................... 24 To Verify that the Driver is Installed Correctly .......................................................................... 24 To Update the Driver ................................................................................................................ 24 Connecting TANGO Automatic BP Unit................................................................................ 24 To Set Up PC-ECG Software .................................................................................................. 25 To Set Up Tango Unit.............................................................................................................. 25 CHAPTER 6: PATIENT PREPARATION .........................................................27 CHAPTER 7: RESTING ECG .............................................................................29 QUICK START ............................................................................................................................. 30 To Perform a New Test ............................................................................................................. 30 Operation with Function Keys.................................................................................................... 30 RESTING 12 LEAD ECG ........................................................................................................... 30 LEADS PLACEMENT ................................................................................................................... 30 To Define the Lead System........................................................................................................ 31 TOOLBAR OVERVIEW................................................................................................................ 31 The Toolbar (Easy Toolbars Mode) ........................................................................................... 31 RESTING ECG SETUP ............................................................................................................... 32 TOOLBAR AND MENUS.............................................................................................................. 35 USING THE MATLAB FEATURE WITHIN PC-ECG 1200 ....................................................... 39 Example of ECG Display with MATLAB............................................................................. 40 CHAPTER 8: STRESS ECG .................................................................................41 To Customize the Display ......................................................................................................... 41 To Lock Screen Window Borders............................................................................................... 41 QUICK START ............................................................................................................................. 42 To Perform a New Test ............................................................................................................. 42 To Print an ECG..................................................................................................................... 42 To Print a Report...................................................................................................................... 42 vii LEADS PLACEMENT....................................................................................................................43 To Define the Lead System.........................................................................................................43 OPERATION WITH FUNCTION KEYS........................................................................................43 TOOLBAR OVERVIEW ................................................................................................................44 Main Toolbar (Easy Toolbars Mode).........................................................................................44 Stress Test Commands ...............................................................................................................44 Views and Filters Toolbar .........................................................................................................45 Average Viewer Toolbar ............................................................................................................45 Post Processing Options Toolbar .................................................................................................46 STRESS ECG SETUP....................................................................................................................47 TOOLBAR AND MENUS: MAIN ..................................................................................................52 TOOLBAR AND MENUS: STRESS TEST COMMANDS ...............................................................53 TOOLBAR AND MENUS: AVERAGE VIEWER ...........................................................................54 TOOLBAR AND MENUS: POST PROCESSING............................................................................54 To Start the Stress Recording Program........................................................................................55 To Start a New Test..................................................................................................................55 Recovery Phase ...........................................................................................................................56 VIEWING RESULTS .....................................................................................................................56 To View Study Results ..............................................................................................................57 To Display the Review Screen Automatically ..............................................................................57 To Display the Review Screen Manually.....................................................................................57 To Save Study Results................................................................................................................57 METABOLIC STRESS ESTIMATION (METS).............................................................................58 TRANSFER FILE TRNSF.TXT ..................................................................................................58 To Transfer a File......................................................................................................................58 ADDITIONAL FEATURES............................................................................................................59 To Define Max. HR .................................................................................................................59 To Define Worst ST ..................................................................................................................59 RS232 CONTROLLED TREADMILL TYPES ...............................................................................60 RS232 CONTROLLED BICYCLE ERGOMETERS .......................................................................61 CHAPTER 9: LATE POTENTIAL SIGNAL AVERAGING ............................. 63 QUICK START ..............................................................................................................................64 To Start a New Test..................................................................................................................64 To Print.....................................................................................................................................64 OPERATION WITH FUNCTION KEYS........................................................................................65 LEADS...........................................................................................................................................65 LP SIGNAL AVERAGING SETUP................................................................................................66 TOOLBAR AND MENUS ..............................................................................................................68 INTERPRETING RESULTS ...........................................................................................................70 Numerical Results......................................................................................................................71 CHAPTER 10: MONITORING ............................................................................ 73 QUICK START ..............................................................................................................................74 To Start a New Test..................................................................................................................74 viii Instructions for Use and Technical Description To Print .................................................................................................................................... 74 Print Study (print a selected time range and leads) ...................................................................... 74 MONITORING ECG SETUP....................................................................................................... 74 TOOLBAR AND MENUS.............................................................................................................. 77 CHAPTER 11: HEART RATE VARIABILITY (HRV) ........................................79 QUICK START ............................................................................................................................. 80 To Start a New Test ................................................................................................................. 80 To Print an HRV Report......................................................................................................... 80 To Print an ECG..................................................................................................................... 81 HRV SETUP ................................................................................................................................ 81 STARTING A STUDY ................................................................................................................... 83 To Add or Subtract an Interval ................................................................................................. 83 To Edit Interval Names ............................................................................................................ 83 To Import or Save GDT/BDT Format.................................................................................... 83 RESULTS DISPLAY ...................................................................................................................... 84 HRV INTERVAL MEASUREMENT............................................................................................. 84 CHAPTER 12: MEASUREMENTS/ INTERPRETATION................................85 QUICK START ............................................................................................................................. 86 To Start Measurements.............................................................................................................. 86 To Print Reports ....................................................................................................................... 86 PERFORMING CHANGES IN CALCULATIONS.......................................................................... 86 To Move the QRS Marker........................................................................................................ 86 To Add or Remove a Wave Marker .......................................................................................... 86 To Move the Wave Marker ....................................................................................................... 87 FEATURES ................................................................................................................................... 87 To View the Measurements on a QRS ...................................................................................... 87 To View the Measurements on a Channel.................................................................................. 87 To View the Measurements on All Channels for QT................................................................. 87 TABULAR SCREEN ...................................................................................................................... 87 AVERAGES DISPLAY .................................................................................................................. 88 QRS DISPLAY ............................................................................................................................. 89 TOOLBAR OF AVERAGES/QRS DISPLAYS.............................................................................. 90 CALIPER DISPLAY ...................................................................................................................... 91 Toolbar of Caliper Display ........................................................................................................ 91 TOOLBAR AND MENUS.............................................................................................................. 92 CHAPTER 13: DATABASE APPLICATION ........................................................95 First Time Use.......................................................................................................................... 96 COMPARING REST TESTS.......................................................................................................... 97 To Compare Rest Tests.............................................................................................................. 97 DATABASE SETUP ...................................................................................................................... 98 TOOLBAR AND MENUS.............................................................................................................. 98 APPENDIX A: INTERFACING WITH INFORMATION SYSTEMS.............. 101 ix DEMOGRAPHIC DATA............................................................................................................. 101 HL7 FORMAT FILE .................................................................................................................. 103 GDT/BDT TYPE COMMUNICATION................................................................................... 105 SAVING THE STRESS TEST AS A RAW DATA (NATIVE BINARY) FORMAT FILE........... 106 SAVING THE MONITOR TEST AS A RAW DATA (NATIVE BINARY) FORMAT FILE ..... 107 APPENDIX B: TECHNICAL SPECIFICATIONS .............................................108 1200W (TRANSMITTER).......................................................................................108 1200WR (RECEIVER).............................................................................................110 APPENDIX C: REPORT SAMPLES .................................................................... 111 APPENDIX D: TROUBLESHOOTING ..............................................................116 USB DRIVER IS NOT INSTALLED PROPERLY ON WINDOWS XP DURING PC-ECG INSTALLATION ......................................................................................................................... 116 Problem................................................................................................................................... 116 Solution .................................................................................................................................. 116 RECOVERING ECG DATA AFTER UNEXPECTED SHUTDOWN OF THE STRESS APPLICATION ........................................................................................................................... 117 Problem................................................................................................................................... 117 Solution .................................................................................................................................. 117 WORKING IN AUTOSAVE MODE WITHOUT SAVING MODIFICATIONS........................... 117 A THICK STRAIGHT LINE IS DISPLAYED FOR ALL LEADS ................................................ 118 Problem................................................................................................................................... 118 Solution .................................................................................................................................. 118 NOISY ECG SIGNAL ON LEADS............................................................................................ 118 Problem................................................................................................................................... 118 Solution .................................................................................................................................. 118 MISSING DATA AFTER A THICK LINE .................................................................................... 119 Problem................................................................................................................................... 119 Solution .................................................................................................................................. 119 x Instructions for Use and Technical Description List of Figures FIGURE 1: SAVING STRESS SETUP....................................................................................11 FIGURE 2: PC-ECG 1200W.............................................................................................15 FIGURE 3: USB CABLE ....................................................................................................16 FIGURE 4: 1200 WR RECEIVER .......................................................................................18 FIGURE 5: ELECTRODE PLACEMENT ................................................................................27 FIGURE 6: RESTING ECG MAIN SCREEN .........................................................................29 FIGURE 7: RESTING ECG TOOLBAR ................................................................................31 FIGURE 8: STRESS ECG RESULTS SCREEN ......................................................................41 FIGURE 9: MAIN STRESS TOOLBAR .................................................................................44 FIGURE 10: STRESS TEST COMMANDS TOOLBAR.............................................................44 FIGURE 11: STRESS ECG VIEWS AND FILTERS TOOLBAR ................................................45 FIGURE 12: STRESS ECG POST PROCESSING DISPLAY TOOLBAR ....................................45 FIGURE 13: STRESS ECG PLAYBACK TOOLBAR ..............................................................46 FIGURE 14: CHANGE TEST PROTOCOL.............................................................................55 FIGURE 15: PATIENT DATA ENTRY..................................................................................56 FIGURE 16: LATE POTETIAL SIGAL AVERAGIG SCREE.......................................63 FIGURE 17: LP SIGNAL AVERAGING REVIEW SCREEN.....................................................70 FIGURE 18: MONITORING SCREEN ...................................................................................73 FIGURE 19: HRV RESULTS ..............................................................................................84 FIGURE 20: MEASUREMENTSTABULAR SCREEN ..........................................................85 FIGURE 21: MEASUREMENTSAVERAGES DISPLAY.......................................................88 FIGURE 22: MEASUREMENTSQRS DISPLAY .................................................................89 FIGURE 23: TOOLBAR OF AVERAGES/QRS ......................................................................90 FIGURE 24: MEASUREMENTSCALIPER .........................................................................91 FIGURE 25: TOOLBAR OF CALIPER...................................................................................91 FIGURE 26: DATABASE MAIN SCREEN.............................................................................95 FIGURE 27: DATABASE PATIENT QUERY .........................................................................96 FIGURE 28: DATABASE PROPERTIES OF SELECTED TEST..................................................97 FIGURE 29: REST REPORT..............................................................................................111 FIGURE 30: STRESS APPLICATIONS - COMPREHENSIVE REPORT ....................................112 FIGURE 31: ECG MONITORING REPORT ........................................................................113 FIGURE 32: HEART RATE VARIABILITY REPORT...........................................................114 FIGURE 33: LATE POTENTIAL REPORT...........................................................................115 xi List of Tables TABLE 1: MINIMUM COMPUTER CONFIGURATION ............................................................ 7 TABLE 2: PRINTERS INSTALLATION REQUIREMENTS......................................................... 8 TABLE 3: PROGRAM ICONS ............................................................................................... 9 TABLE 4: D/A BOARD 0 TO+4 VOLT............................................................................... 21 TABLE 5: D/A BOARD 4 TO +4 VOLT ............................................................................ 22 TABLE 6: OPERATION WITH FUNCTION KEYS ................................................................. 30 TABLE 7: RESTING ECG SETUP OPTIONS ....................................................................... 35 TABLE 8: RECORDING RESTING ECG ............................................................................. 39 TABLE 9: STRESS FUNCTION KEYS ................................................................................. 43 TABLE 10: STRESS ECG SETUP OPTIONS........................................................................ 51 TABLE 11: MAIN STRESS TOOLBAR AND MENUS............................................................ 52 TABLE 12: STRESS TEST COMMANDS ............................................................................. 53 TABLE 13: AVERAGE VIEWER TOOLBAR ........................................................................ 54 TABLE 14: POST PROCESSING TOOLBAR AND MENUS..................................................... 55 TABLE 15: TRANSFER FILE FORMAT............................................................................... 58 TABLE 16: CONTROLLED TREADMILLS ........................................................................... 60 TABLE 17: CONTROLLED ERGOMETERS.......................................................................... 61 TABLE 18: LP SIGNAL AVERAGING FUNCTION KEYS ..................................................... 65 TABLE 19: LP SIGNAL AVERAGING LEADS PLACEMENT ................................................ 65 TABLE 20: LP SIGNAL AVERAGING SETUP ..................................................................... 67 TABLE 21: LP SIGNAL AVERAGING TOOLBAR AND MENUS............................................ 69 TABLE 22: LP SIGNAL AVERAGING NUMERICAL RESULTS............................................. 71 TABLE 23: MONITORING SETUP OPTIONS ....................................................................... 76 TABLE 24: MONITORING TOOLBAR AND MENUS ............................................................ 78 TABLE 25: HRV SCREEN ................................................................................................ 80 TABLE 26: MEASUREMENTS TOOLBAR AND MENUS....................................................... 94 TABLE 27: DATABASE SETUP OPTIONS........................................................................... 98 TABLE 28: DATABASE TOOLBAR AND MENUS .............................................................. 100 TABLE 29: STRESS RAW DATA FILE FORMAT............................................................... 106 TABLE 30: MONITOR RAW DATA FILE FORMAT ............................................................ 107 Introduction 1 CHAPTER 1:

INTRODUCTION Manual Organization This manual explains in detail how to install and use the PC-ECG 1200. At the beginning of each application chapter, there is a Quick Start section, which is a brief explanation of how to carry out a study, including the keyboard short-cuts for the main functions. If you are familiar with ECG procedures, you can use this Quick Start section to get up and running quickly. The software must be installed before the hardware. See Software Installation, page 7 and Hardware Installation, page 13. Document Conventions Notes and Cautions Pay particular attention at specific points in a procedure when one of the following messages appears:

W A R N I N G

Ca u t io n N o t e Warnings call attention to possible hazards involving potential damage or injury to persons. Cautions refer to practices necessary to protect against potential damage or loss to equipment. Pay careful attention to instructions. Notes provide pertinent information to help obtain optimum performance from the software or signify an important step or procedure that requires special attention. NV-54/PCECG1200W 2 Instructions for Use and Technical Description Abbreviations and Acronyms Abbreviation Meaning BP ECG Blood pressure Electrocardiogram Database Database application HRV ID LP LQTS METS SN USB Heart Rate Variability Identification Late Potential Long QT Syndrome Metabolic Stress Estimation Serial Number Universal Serial Bus Equipment Symbols Symbol Description Defibrillated CF type equipment Class II equipment Complies with the Medical Device Directive of the European Union Attention, consult ACCOMPANYING DOCUMENTS Non-ionizing radiation. Norav Medical Ltd. Overview 3 CHAPTER 2: OVERVIEW Package Contents The PC-ECG 1200W package contains the following elements:

Wireless Acquisition box PCECG1200W (page 15) Patient leads USB cable 1200WR Receiver Antenna Software CD with the PC-ECG 1200 installation package, including:

Rest Stress Monitor HRV LP Database Software key (if optional software is included) NV-54/PCECG1200W 4 Instructions for Use and Technical Description Programs Each program has a specific purpose. The following is a brief description of when to use each one:

Rest Records and measures short ECG tests on patients in resting position (up to 10 seconds) Records and measures ECG tests on patients under stress conditions using a pre-

defined test protocol. The stress test includes 3 basic stages:

Stress Monitor HRV LP Rest Stress Recovery Each stage may be divided into more than one phase according to the testing protocol used. Works with an ECG device to record, monitor and save a prolonged ECG test in rest condition Tests according to time how patient pulse and heart rate varies with load, medication, etc. Predicts tendency to ventricular tachycardia Database ECG Database Management System. Manages patients and ECG tests details. PC-ECG Models 1200 W Wireless ECG Recording test during stress and rest condition (attached to patients body) Norav Medical Ltd. Overview 5 Indications for Use of the PC-ECG 1200 ECG Intended Use ECG is intended to disclose either normal condition or patterns of arrhythmia, myocardial ischemia, rate abnormalities, or features of prognostic value in the following cases:

Patients with suspected cardiac abnormalities Populations of patients at an age or period in which a routine baseline evaluation of ECG characteristics is desired. QT Analysis is useful in the assessment of long QT syndrome (LQTS). In some instances, LQTS can be corrected by pharmacological therapy. QT analysis is also used to measure QT dispersion, the difference between maximal and minimal QT values. QT dispersion is a measure of the inhomogeneity of ventricular repolarization. The PC ECG 1200 has been tested to measure Heart Rate Variability to within 1 millisecond tolerance. The clinical significance of Heart Rate Variability measures should be determined by a physician. The PC ECG 1200 has been tested to measure Late Potential to a tolerance of within 1 millisecond, and 1 microvolt. The clinical significance of Late Potential measures should be determined by a physician. Stress Testing Intended Use Angina pectoris (chest pain) is a clinical syndrome resulting from myocardial ischemia, indicative of reduced blood supply to the cardiac muscle. The electrocardiogram may establish the diagnosis of ischemic heart disease if characteristic changes are present. Stress testing is the most widely used method to decide whether this chest pain is related to myocardial ischemia, and thus to coronary artery disease. In stress testing, the contractile capability of the heart muscle is monitored via ECG during patient exercise. Patients exercise by bicycle, treadmill, or other means, while the ECG is monitored continuously. Exercise loads are determined by predefined protocols. The ECG signals are recorded for the resting, exercise, and recovery phase portions of the exercise protocol. The changes in ECG waveforms are compared to the resting ECG records. Most of the commercial stress test systems control the bicycle or treadmill automatically according to the requirements of the chosen protocol, although this is not essential. ST segment monitoring is intended as an aid in the evaluation of myocardial ischemia in patients with known or suspected coronary artery disease. The ST segment algorithm has been tested for accuracy of the ST segment data, and a database is used as a tool for performance testing. The significance of the ST segment changes must be determined by a physician. NV-54/PCECG1200W 6 Instructions for Use and Technical Description Contraindications for Use and Adverse Effects The device has no contraindications or adverse events. Norav Medical Ltd. Software Installation 7 CHAPTER 3: SOFTWARE INSTALLATION System Requirements and Prerequisites Hardware N o t e N o t e Stress application with real-time printout is resource intensive. To optimize performance, we recommend that you disable Start Up programs to free system resources. For instructions, see Windows help. The PC should not be set up to work under saving power conditions. Do not enable PC sleep mode (standby), hibernate, or turning off the hard disk while running an ECG test. PC Minimum Configuration Application CPU Speed

(MHz) Rest Monitoring Application LP HRV Database Stress Stress + R trigger Stress + Blood pressure monitor 100 200 450 450 200 1000 1300 1500 RAM Memory Disk Space (GB) Number

(MB) 32 32 128 128 64 128 128 128 of Free RS232 or USB Ports 1 1 1 1 1 2 2 3 2 4 2 2 8 20 20 20 Table 1: Minimum Computer Configuration NV-54/PCECG1200W 8 Instructions for Use and Technical Description Installing Printers Application Technology RAM Memory

(MB) Driver Rest LASER/INK Monitoring Application LASER/INK LP HRV Database Stress LASER/INK LASER/INK LASER/INK Fast LASER 2 2 2 2 2 8 Vendor / MS Vendor / MS Vendor / MS Vendor / MS Vendor / MS MS Table 2: Printers Installation Requirements Installing the Thermal Printer Use a 4 inch or 8 inch thermal printer. The thermal printer driver is installed separately from the PC-ECG 1200 program. A thermal printer can be supplied by Norav (MP200, 8 inch). This printer requires the purchase of a dongle with P1 license permission. The MP200 driver is available on the PC-ECG 1200 CD at the following path: "<CD>:\MP200\OEMPRINT.inf". Installing or Updating The PC Software Install the software before installing the hardware. If the device is connected to the PC, disconnect the device before installing the software. N o t e :

The software package works under Windows NT, 98, ME, 2000, and XP operating systems. Norav Medical Ltd. Software Installation 9 To Install PC-ECG 1200 1. Insert the CD in the drive. The installation program starts automatically. 2. Follow the instructions on-screen.0. After you have completed installation, a group icon called PC-ECG 1200 is added to the desktop. Double-click the group icon to display the following program icons:

Icons are displayed only for those programs for which you have purchased the license N o t e :

Icon Explanation Heart Rate Variability Late Potential Signal Averaging Monitoring Resting ECG Stress Test Database application Table 3: Program Icons Resting ECG is the basic software package. It does not require a software key. The following are optional and require software keys:

Measurement and interpretation functions for Resting ECG NV-54/PCECG1200W 10 Instructions for Use and Technical Description ECG Database Heart Rate Variability Late Potential Monitoring Stress Test You can activate optional packages that have no key by selecting Simulator in Setup

(see Simulator ECG, Page 32). If you have purchased the S2 remote viewing, install the Remote View program from the Remote View directory on the CD. This program enables a remote viewer for an ECG study. The image is displayed in JPEG format. To Uninstall PC-ECG 1200 New Version Replacing Old Version There is no need to remove the previous installation. The existing setup will remain for the new version. If the new software version does not operate properly, remove the old installation (see Old Version Replacing New Version, below) and then remove the old existing setup as follows:

Start  Run Type regedit OK Choose HKEY_CURRENT_USER 

Software NORAV MEDICAL Edit Delete Old Version Replacing New Version Uninstall the existing version as follows:

My Computer  Control Panel  Add/Remove Programs  PC-ECG 1200 

Add/Remove  OK To Free Disk Space and Ensure Smooth Operation Windows provides utilities to delete superfluous files, and to defragment the disk. Refer to Windows help for instructions on using Disk Cleanup and Defragment. Backing up and Restoring Setups and Protocols When you reinstall or upgrade PC-ECG 1200, the program overwrites your existing configurations and protocols. To save the configuration data for stress application, follow these procedures:

Norav Medical Ltd. Software Installation 11 To Save Stress Test Setup 1. Start Stress ECG. 2. Click View\Save Setup (see Figure 1). Figure 1: Saving Stress Setup 3. Name the file. 4. Provide a location in which to save the file and Click OK. To Load Stress Test Setup 1. Start Stress ECG. 2. Click View\Load Setup. 3. Click Browse and find the location in which the file is saved. 4. Select the file (with the name you gave it and the suffix STF) and click OK. To Save Stress Protocols 1. Create a new directory in C:\My Documents, with a name like PcBackup. 2. Copy file StWorked.mdb from the directory where PC-ECG is installed (normally C:\Program Files\PC-ECG). 3. Paste it into a backup directory (e.g., C:\My Documents\PcBackup). NV-54/PCECG1200W 12 Instructions for Use and Technical Description To Load Stress Protocols 1. Copy the file StWorked.mdb from the directory where you saved it

(e.g., C:\My Documents\PcBackup). 2. Paste it into the directory where PC-ECG is installed (normally C:\Program Files\PC-ECG). A window is displayed, asking you if you would like to replace the existing file. 3. Click Yes. To Set Preferences 1. After installing the PC-ECG 1200 package, and prior to operation, click Setup to tailor your preferences. 2. Begin with Environment, which configures the hardware. 3. Continue with the other tabs in any order. Norav Medical Ltd. Hardware Installation 13 CHAPTER 4: HARDWARE INSTALLATION Safety W A R N I N G The PC-ECG 1200W transmitter uses battery power supply. PCECG1200WR receiver uses Power supply via USB port. It is also sensitive to electrical interference. The PC-ECG 1200 controls exercise machines. To prevent possible injury, read this page carefully prior to installing the device. A patient undergoing a test must be at a distance of at least:

1.5 meters from the computer, printer and other peripherals, If such conditions cannot be fulfilled, the entire system needs to be connected to the A/C power supply through an Isolation transformer meeting the EN60601/1 standard. Use only the recommended battery type as instructed in the technical specifications to operate the PCECG1200W (4 - AA alkaline or NIMH rechargeable). Do not use batteries with expired dates. Remove batteries form the PCECG1200W when it is not in use. Any treadmill used with the PC-ECG 1200 must contain a manual control in order to allow the user to stop the operation of the treadmill in case of emergency. In the event of apparent changes in the performance of the device, discontinue use immediately. Do not resume use until the device is approved by the manufacturer or by a representative of the manufacturer. If audio is playing on the PC, the ECG shows interference. Do not run an audio CD on the PC while running an ECG test via the USB connection. Defibrillation protection is built in for Model W. Operate the unit only at clinics and hospitals. Do not use at home. Operation only by trained medical staff. NV-54/PCECG1200W 14 Instructions for Use and Technical Description This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions:

(1) This device may not cause harmful interference and

(2) This device must accept any interference received, including interference that may cause undesired operation. N o t e N o t e The manufacturer is not responsible for any Radio or TV interference caused by unauthorized modifications to this equipment. Such modifications could void the users authority to operate the equipment. Install hardware only after software installation. CLASSIFICATION OF THE EQUIPMENT

- According to the type of protection against electric shock:

INTERNALLY POWERED EQUIPMENT

- According to the degree of protection against electric shock:

TYPE CF APPLIED PART

- According to the degree of protection against ingress of water:

ORDINARY EQUIPMENT

- According to the degree of safety of application in the presence of a flammable anaesthetic mixture with air or with oxygen or nitrous oxide:

EQUIPMENT NOT SUITABLE FOR USE IN THE PRESENCE OF A FLAMMABLE ANAESTHETIC MIXTURE WITH AIR OR WITH OXYGEN OR NITROUS OXIDE.

- According to the mode of operation: CONTINUOUS OPERATION Norav Medical Ltd. Hardware Installation 15 Installing Model 1200W The PC-ECG 1200W kit contains the following items:

Acquisition box (see Figure 2, below) Patient leads USB cable (see Figure 3, page 16) Antenna 2 3 1200 WR receiver (see Figure 4, page 18) Software CD of PC-ECG 1200 installation package. Software key (if optional software is included) 4 1 Figure 2: PC-ECG 1200W NV-54/PCECG1200W 16 Instructions for Use and Technical Description 1 2 Figure 3: USB Cable Norav Medical Ltd. Hardware Installation 17 To Connect Via USB

Ca u t io n Make sure the device is switched off Cautions refer to practices necessary to protect against potential damage or loss to equipment. 1. Connect Antenna (Figure 4, Page 18, detail 4) to the connector on 1200WR Receiver (Figure 4, Page 18, detail 2). 2. Connect the A-type connector of the USB cable (Figure 3, Page 16, detail 1) to the PC. 3. Connect the B-type connector of the USB cable (Figure 3, Page 16, detail 2) to the input of the 1200WR Receiver (Figure 4, Page 18, detail 1). 4. A wizard for installing new hardware driver appears. Follow the instructions. If working under Windows XP press Continue anyway on message regarding the digital signature (each time it appears). After the driver is installed make sure the green light is illuminated on the 1200 WR Receiver (Figure 4, Page 18, detail 3) 5. Insert 4 - AA alkaline or NIMH rechargeable batteries into the battery compartment of the PCECG1200W unit. 6. Switch on the PC-ECG 1200W (Figure 2, Page 15, detail 2) and verify that the ON light is illuminated Figure 2, Page 15, detail 3). 7. Connect the 10 patient leads according to the lables to the 10 connectors of the PC-ECG 1200W (Figure 2, Page 15, detail 1). 8. 9. If the optional software key is included, connect it to the parallel port of the computer. If a printer is connected via the parallel port, plug the printer cable into the key. The optional BNC output (Figure 4, Page 18, detail 5) is a trigger control for connecting to an external device, such as an ergometer or the Tango unit. NV-54/PCECG1200W 18 Instructions for Use and Technical Description 3 5 1 2 4 Figure 4: 1200 WR Receiver To Verify the Connections 1. Connect the PC-ECG 1200W to the patient. 2. Connect the electrode leads to the electrodes, starting with RL. 3. Verify that an ECG is acquired and displayed on the screen. To Perform Maintenance

Ca u t io n The device is not waterproof. Do not expose the device to water or any kind of liquid. Maintain in a dry place. 1. Use alcohol pads to clean the device of moisture and hairs. 2. Replace the pouch or wash it at 300C. Norav Medical Ltd. Hardware Installation 19 Calibration The device does not need any calibration. Connecting an Exercise Device You can connect a treadmill or ergometer to the computer independently of the PC-ECG 1200W. You can also operate the exercise device without using an ECG recorder by using the software with Simulator option selected. To Connect an RS232 Controlled Treadmill/Ergometer Connect the RS232 cable (as specified by the vendor) to COM 2 (if COM 2 is in use, then wait until the software has been installed and use the assigned COM port). To Connect an Analog Controlled Treadmill/Ergometer A digital/analog converter (D/A) board converts the digital signal from the computer into an analog signal that the treadmill or ergometer can read. 1. Insert the D/A board into the PC. 2. Connect the cable from the D/A board as specified in the D/A board table. Cabling The RS232 cable should contain at least 3 wires: TD, RD using pin 2 and 3 and GROUND using pin 5. Straight type means that pin 2 on the PC side connects to pin 2 on the exercise device side, pin 3 on the PC side connects to pin 3 on the exercise device side, and pin 5 on the PC side connects to pin 5 on the exercise device side. Crossed type means that pin 2 on the PC side connects to pin 3 on the exercise device side, pin 3 on the PC side connects to pin 2 on the exercise device side and pin 5 on the PC side connects to pin 5 on the exercise device side. To Determine Treadmill Cabling Check which pins are assigned for TD and RD on the exercise device connector. If pin 2 is RD and pin 3 is TD, then the exercise device requires a crossed cable If pin 2 is TD and pin 3 is RD, then the exercise device requires a straight cable. NV-54/PCECG1200W 20 Instructions for Use and Technical Description Connecting a Blood Pressure Stress Monitor To Connect a Blood Pressure stress Monitor 1. Insert the D/A board into the PC and connect the cable from the D/A board to the BNC input on the monitor. 2. Connect the RS232 cable (as specified by the monitor vendor) to COM 4. If COM 4 is in use, wait until the software is installed and use the assigned COM. Norav Medical Ltd. Accessories Installation 21 CHAPTER 5: ACCESSORIES INSTALLATION D/A Board: Model: CIO-DAC02 for ISA Bus The software uses a digital signal, but the exercise device (treadmill or ergometer) operates through an analog signal. To make communication possible, the D/A board converts the digital signal into an analog signal. Jumpers Setting D/A0=

D/A1=

WAIT STATE=

-5

-5 Off Settings and Output of the D/A Board for 0-4 Volt Output Board P/N and Board target Board address and address switches Common pin no. on D25 connector D1-a Treadmill Analog control D1-a Ergometer Analog control D1-s Metabolic Interface D1-t ECG Trigger 300H. switches 8,9 DOWN the rest UP 300H. switches 8,9 DOWN the rest UP 304H. switches 8,9,2 DOWN the rest UP 308H. switches 8,9,3 DOWN the rest UP 1 1 1 1 Out 1 pin no. on D25 connector Speed pin : 24 Out 2 pin no. on D25 connector Grade pin: 18 Power pin : 24 Heart Rate Work Load pin: 24 pin: 18 TTL OUT pin: 24 Table 4: D/A Board 0 to+4 Volt NV-54/PCECG1200W 22 Instructions for Use and Technical Description Settings and Output of the D/A Board for -4 to +4 Volt Output Board P/N and Board target Board address and address switches Common pin no. on D25 connector Out 1 pin no. on D25 connector Out 2 pin no. on D25 connector D1-a Treadmill Analog control D1-a Ergometer Analog control D1-s Metabolic Interface 300H. switches 8,9 DOWN the rest UP 300H. switches 8,9 DOWN the rest UP 304H. switches 8,9,2 DOWN the rest UP 1 1 1 Speed Pin: 23 Power pin: 23 Grade pin: 17 Heart Rate Work Load pin: 23 pin: 17 Table 5: D/A Board 4 to +4 Volt To Continue Setup (After Installing the ISA Board/s) 1. In Stress ECG, click Setup > Environment. 2. Select the Advance tab. 3. Check the appropriate boxes for R-wave Trigger, USB Connection, and Cards. Norav Medical Ltd. Accessories Installation 23 PCI Bus Board Functioning as an ECG Trigger The ECG trigger function can be provided either via the PCI bus board (see immediately below) or by connecting to the 1200 USB through the BNC output. The Stress application can control an analog/trigger signal. The analog/trigger control can be configured in the setup dialog for connection through either the PCI card or the 1200 USB adaptor. To Set Up an ECG Trigger via PCI Bus Board Install the board as instructed by the manufacturer. Install the PCI-DIO24 driver from the CD before connecting the Tango device. If the device was connected before the driver is installed, then cancel the Add New Hardware wizard, disconnect the Tango device, and install the software. N o t e To Complete Setup 1. Click Stress Setup > Environment. 2. Click the Advance tab. 3. Check the appropriate boxes for R-wave Trigger, USB Connection, and Cards. Cable for PCI board Connector pin 21 on D37 connectorcommon Connector pin 37 on D37 connectorTTL The target side can be either BNC or PHONO. NV-54/PCECG1200W 24 Instructions for Use and Technical Description Installation of the TANGO Automatic BP Unit You must install the PCI-DIO24 driver from the CD before connecting the Tango device. If the device was connected before the driver was installed, then cancel the Add New Hardware wizard, disconnect the Tango device, and install the software. N o t e 1. Insert the PCI-DIO24 card driver CD in the CD driver. 2. Select Install InstaCall from the menu displayed. 3. Follow the instructions. To Verify that the Driver is Installed Correctly 1. Right click My Computer on the desktop and select Properties from the pop-up menu. 2. Select Hardware tab from the dialog box and click Device Manager. 3. Locate the icon next to Das Computers PCI-DIO24. If the icon has no accompanying marks, then it is correctly installed. If it is checked with ? or !,update the driver, as explained below. To Update the Driver 1. Double click the icon and click Update Driver. 2. Select Install the software automatically and click Next. 3. Define the path for the driver as C:\Windows\inf\OEM XX.inf and follow the instructions on screen to complete the installation. Connecting TANGO Automatic BP Unit

(Requires Option S1 or S2) The Tango unit connects to the PC by 2 cables:

1. RS232 modem cable both sides female D9 connectors. Pin 2 --------------------Pin 3 Pin 3 --------------------Pin 2 Pin 5 --------------------Pin 5 Norav Medical Ltd. Accessories Installation 25 2. R-R trigger cable connecting board D1-t (plugged in PC) by D37 (D25 on old boards) connector to the BNC socket of the Tango. To Set Up PC-ECG Software 1. In Environment, assign a COM port for Automatic Blood Pressure COM Port and check R-Wave Trigger. 2. In Protocols, check Measure BP by automatic device To Set Up Tango Unit The configuration of the Tango unit for communication should be SUNTECH (as device) and DKA (as technique). Define these as follows:

TEST PARAMETERS, TECHNIQUE = DKA UTILITIES, DEVICE = SUNTECH NV-54/PCECG1200W Patient preparation 27 CHAPTER 6: PATIENT PREPARATION The ECG traces quality depends very much on the stability and conductivity of the electrodes during the test, especially during high stages when the patient movements can cause artifacts. Here are some basic rules to ensure good electrical contact:

Shave hair at the electrode contact points Use a special shirt that attaches the electrodes and lead wires to the body Use high quality liquid gel electrodes Make sure that the lead wires do not swing Attach the leads as shown in Figure 5, below (RA=right arm, LA=left arm, RL=right leg, LL=left leg). Figure 5: Electrode Placement NV-54/PCECG1200W Resting ECG 29 CHAPTER 7: RESTING ECG Program Menu bar Toolbar Blood pressure systole/diastole

(user input) Heart rate

(beats/min) Timed recording Selected strip display (strip lead) Multiple lead display Horizontal

(mm/sec) and vertical

(mm/mV) scale Figure 6: Resting ECG Main Screen NV-54/PCECG1200W 30 Instructions for Use and Technical Description Quick Start To Perform a New Test 1. Click F1 (or the New button on the tool bar). 2. Insert patient details in the dialog box. 3. Click OK. 4. Enter blood pressure. 5. Click F2 to stop data collection or F3 to start data collection (10 seconds). Operation with Function Keys F1 New Recording F2 F3 F6 Start/Stop 10 sec. recording Print F11 Open Saved Study Table 6: Operation with Function Keys For an example of a printed report, see Appendix C:, page 111. Resting 12 Lead ECG This application uses the standard 10 contact cables. It contains four limbs (RA, LA, LL, and RL) and six chest (V1-V6) contacts. 12 derivations are recorded and displayed:

3 Bipolar derivations: I, II, III 3 Augmented derivations: aVR, aVL, aVF 6 Unipolar derivations: V1-V6 You can use a simpler cable with four contacts (only limbs). It produces six derivations only: three Bipolar and three Augmented Leads Placement You can place the leads on the patient in various ways. The usual method is to place the leads in the standard positions on the chest (V1-V6). To identify the placement of Norav Medical Ltd. Resting ECG 31 the leads, the channels are renamed. Additional options for lead placement are V7-V9, and the Right chest Lead system. To Define the Lead System 1. Click Setup > Lead. 2. Select the lead system to use (Default: Standard). Toolbar Overview The Toolbar (Easy Toolbars Mode) New Print Show patient details View/modify QRS values Start/stop Select Filters Open Set preferences Add remarks Select leads to display Record 10 seconds Figure 7: Resting ECG Toolbar The icons shown on page 35 are from the full toolbar. You can use the view menu to show an abbreviated display with or without captions. N o t e NV-54/PCECG1200W 32 Instructions for Use and Technical Description Resting ECG Setup Click Setup on the Toolbar to access the following parameters:

Tab Leads Option Description Lead Systems Define the lead system to be used and displayed according to the electrode placement on the patient. Choose between Standard, Cabrera, V7-V9, and V3R-V5R lead systems (default: standard system). Default 3 leads Define the 3 leads that will be displayed as default when using 3x1-view format. Default 6 leads Define the 6 leads that will be displayed as default when using 6x1 or 3x2-view format. Strip Lead 10 sec lead to appear in 4x3 and 6x2 formats. Default is cleared. ECG Recording Filter 50/60Hz When checked, the default status of 50/60Hz filter is ON (according to the checked frequency 50 or 60). EMG Filter Baseline Filter Default is cleared. When checked, the default status of the EMG filter is ON. Default is cleared. When checked, the default status of the Baseline filter is ON. Save options Auto stop after 10 sec Auto Print If Auto Save is ON, the file is stored by last name or by ID. If Auto Save is OFF, a dialog box is displayed asking the user to enter a file name. If cleared (default), recording runs till stopped by the user. If checked, stops recording automatically after 10 sec. Use this option for automatic printing of the test at the end of the Rest test. If more than one printer is defined in the network, select the appropriate one from the list. If cleared (default), ECG recording is done from the PC-ECG unit. Simulator ECG If checked, the ECG recording is done from the demo file included in the software package. In this case, the recording unit is not needed. Data Directory Allows the user to define a directory for saved ECG recordings (if ECG database is not used). Use a secondary hard disk, if one is available. Use ECG Database Select this option to connect to the default ECG database. When this option is selected (checked) the ECG tests are saved in the database. Norav Medical Ltd. Resting ECG 33 Tab Option Description BACKUP Data directory for AutoSave mode When Auto Save option is selected, this allows the user to define a local path for a backup directory. The backup directory is useful when the data directory or database is not on the same computer. In such a case, ECG file save can fail due to failure in connection. Diagnosis Optional. Active only if the measurement option (I1) is installed. View ST after J Defines the ST spot relative to the J point. Print Options Draw over lead borders View calibration pulse 1 mV Leads Base line shift Allows the user to determine if and when to have automatic results printed. Define if measurements and/or interpretations should be added to printouts. Options are Never, After Confirmation, or Always. If checked (default), does not limit the extreme high amplitude ECG pulses from exceeding the borders. If cleared, chops the pulses at the borders. If cleared (default), the 1-mV pulse will appear only in printing. If checked, the 1-mV pulse will also appear on the screen. If cleared (default), the base line of each lead is exactly in the middle of the leads area. If checked, a special shift is added to each lead to view its maximum. For example: lead V6, being positive pulsed, gets negative shift. If checked, leads are displayed framed and separated from each other. Separate Leads If cleared, leads are not separated. Default is checked. If checked, displays grid lines when the application is opened. Draw Grid If cleared, the application is opened with no grid lines Default is checked. Horizontal Scale Sets the default value for the horizontal scale window on the screen

(mm/sec). Vertical Scale Sets the default value for the vertical scale window on the screen

(mm/mV). Rest ECG color selection Allows the user to choose colors for the Rest ECG application for background, traces, grid, and text. Restore Defaults When activated, restores the factory default colors: black for background, yellow for traces, green for grid, turquoise for text. Easy Toolbar Mode Text Label If checked, allows the user to use the regular Icons. If cleared, allows the user to use the optional Icons Adds text to the Icons. Enables use by keyboard. NV-54/PCECG1200W 34 Instructions for Use and Technical Description Tab Option Description Installation Saves users data (hospital and physician). This data is printed on any print out and sent as email. Measurement Standard Define whether measurements will be calculated according to the metric or the USA standard. Default is metric. Magnetic Card Reader Select this option to use a magnetic card with bar-code to insert patient details. (Select the magnetic card type.) Environment Connection Select the option button (COM port/USB), to choose the port the device should be connected through. If the COM port option is selected, select the serial input for the PC-

ECG unit from the COM port selection list. If the USB connection is selected, the COM PC-ECG selection list is disabled. (Default at installation is USB). Picture Format Display Size Choose between 14/15-inch screen (default) and 17-inch screen. This setting is required in order to display the ECG and grid in the correct scale. If set to On, prints 1mm and 5 mm squares on printouts. Graph paper Regular Grid is guaranteed to fit any printer. Improved Grid shows a fine grid but may not work on some printers. Paper Size Sets paper size. either conventional printer or 4-inch thermal printer. Large Remarks Font Enables large font for user entered free text. Color Printout Select this option for colored printouts. Shadow/Frame For Area of Interest AutoSave ECG in Picture Format Set File Name By Allows the user to choose between shadow and frame to highlight the interest area. Select this option to save the test automatically as a JPG image. Set the file names to include Patient Last Name or Patient ID. Check date and/or hour to include them in the file name. Picture Format Select the resolution of the picture (normal or high resolution). Picture Directory Set the directory for saved pictures. The default is C:\Program Files\PCECG\Data. GDT/BDT Format Automatic Setup automatic GDT/BDT format. Save test in GDT/BDT Import from GDT/BDT If checked, save test automatically to GDT/BDT format. If checked, imports tests automatically as GDT/BDT format. Norav Medical Ltd. Tab Option Description Resting ECG 35 File Format Select the file format: GDT or BDT. Import Codepage 437 Export Codepage 437 Check this option to import Code page 437. Check this option to export Code page 437. Edit Labels Click this button to open a dialog box with an editable list of the field labels used in the GDT and BDT files. GDT/BDT Data Directory Define the directory path where the GDT/BDT files should be maintained. Token for PCECG Token for Practice EDP Default is PEKG. Default is EDV1. Text File Auto Save Test Data in Text file Select this option to save the test data in a text file automatically at the end of the rest test. Set Text file Name by Set the text file name according to Test File Name or according to the fields Patient ID and/or Patient Last Name. Text File Data Directory Set the directory path to maintain the text files with the ECG data. Default is C:\Program Files\PCECG\Data. Table 7: Resting ECG Setup Options Toolbar and Menus To do this Click this icon Or use this short-

cut key Or select this menu Description Start a new study Open an existing study F1 File > New Rest Test Starts a new 12 lead recording. The patient data can be entered prior to ECG recording, but this is not mandatory. The recording time is according to the setup for ECG Recording: either continuous or limited to 10 sec. To stop recording, click GO/STOP. F11 File > Open Shows recordings that are saved on disk. NV-54/PCECG1200W 36 Instructions for Use and Technical Description To do this Click this icon Or use this short-

cut key Or select this menu Description Import Data from SCP Format Import demographic data from HIS to PC-ECG Export the GDT/BDT file from PC-ECG to HIS File > Import from SCP Format (Select the required file(s) and path from the dialog box and click OK) File >

GDT/BDT Format For details see Import from GDT/BDT, page 105 File >

GDT/BDT Format For details see Save Test in GDT/BDT page 105 SCP format is a European format for ECG files. The Rest application can identify these files, import them, and save them as Rest files, either to the database or to the defined folder for the Rest files. This file always contains the last patient data. This file always contains the last patient data. Save a recording Ctrl+S File > Save Saves recording on disk (default file name: REST). Send results via email File > Send Sends recording data via email. If the large icons are used the operation must be performed through the FILE menu Prerequisites: e-mail software package, modem, and internet provider (not included in the PC-ECG 1200 package). Once an ECG study is displayed on the screen of the transmitting side, click this icon to attach the ECG file and send an e-mail to a specified address. The receiver must have the PC-ECG 1200 software installed. A regular email is sent with the ECG as an attached file. The receiver can either double click the file to display the ECG on the screen, or save it in the PC-ECG 1200 studies default directory. Export to MATLAB format Ctrl+E File > Export to Matlab Format Saves ECG results in MATLAB format.

(For details see Using the Matlab Feature within PC-

ECG 1200, page 39). Norav Medical Ltd. Resting ECG 37 Click this icon Or use this short-

cut key Or select this menu Description File > Create Text File File > Save ECG to Picture Format File > Print Average Mini Card Saves ECG data in text format. Saves ECG test as a JPG image. Prints results as a mini-card that can be carried in the pocket or wallet. F6 File > Print Prints the recordings currently shown on the screen. Note that the 1-mV signal is always printed. View > Setup Allows the user to set preferences for Leads, ECG Recording, Diagnosis, View, Installation, Environment, Picture Format, GDT/BDT Format, and Text File. Help > About View > Patient Data For details see Table 7, page 35. Displays software version number (which should be quoted on any software inquiry) software key, and permissions; Norav contact information; memory size and free disk space; HASP ID number (ID of existing software keys). This ID number is used for adding software options. Can be added to the recording. It will be printed together with ECG traces. If the recording is saved, then the PATIENT DATA will be saved together with the ECG traces. Use the Previous option if the same patient undergoes a second study. View >

Remarks\

Interpretation Allows the user to enter free text during or after the ECG recording. This is printed and saved together with ECG traces. If the Interpretation option is installed, then Interpretation Statements is also displayed. To do this Create a text file Save the test as an image Print a miniature printout of results Print results Set preferences Display program, hardware, and contact information Print patient data Add remarks NV-54/PCECG1200W 38 Instructions for Use and Technical Description To do this Click this icon Or use this short-

cut key Or select this menu Description View and modify QRS values View >

Measurements An optional feature that requires a software key (I1 or I2 license). Displays a comprehensive table of measured values. You can alter the values either by editing them in the table or by using Caliper to change the horizontal and vertical markers. When Caliper is activated, a large QRS is shown with the standard markers. Open the Standard Markers window (upper right side) and select the QRS interval of interest for modification. The area changes to blue. Use the mouse to move the markers.

(For details see Measurements/ Interpretation, page 85). Display/hide the grid Display information from different leads (5 options) Display 3x4 Display 6x2 Display 12x1 Display 6x1 Display 3x1 View/print averages View > Grid Displays or hides the 5mm raster grid. Print outs are always with 1mm raster. View > Leads Format > 3x4 Windows View > Leads Format > 6x2 Windows View > Leads Format > 12 Leads View > Leads Format > 6 Leads View > Leads Format > 3 Leads Classical format. 12 lead ECG of 2.5sec ECG + 10sec trace.*

12 lead ECG of 5sec ECG + 10sec trace.*

12 lead ECG of 10sec ECG.*

6 lead ECG of 10sec ECG.*

3 lead ECG of 10sec ECG.*

Produces a typical QRS for every lead from the raw ECG data. The averages can be printed either full size or minimized in a credit card size. To perform a miniature print, enter FILE and then PRINT MINIATURE. Norav Medical Ltd.

Resting ECG 39 To do this Click this icon Or use this short-

cut key Or select this menu Description Scroll between displays from different leads View > Leads Format > Next leads Double function:

Scrolls for all leads in the 3X1 display Points to the requested lead Start/stop ECG Record a 10 second segment Start/stop 50/60 Hz filter Start/stop EMG filter F2 ECG >

Start/Stop Controls start and stop of ECG recording. F3 ECG > 10 Sec Start 10-sec timer for recording ECG data. ECG > Filters

> 50/60 Hz ON/OFF for line interference filter. Set Options for 50 or 60 Hz prior to operation. ECG > Filters

> EMG ON/OFF for muscle noise filter. Compare View >

Compare Tests Select two or more Rest tests from the Database interface and click Compare. This option is only available when you check Setup > ECG Recording >

Use ECG Database. Click Compare again to end Compare mode and display the Rest test. ECG data can be set up as limited amplitude or unlimited amplitude, which can cause one lead data to overlap a neighboring lead.

Table 8: Recording Resting ECG Using the Matlab Feature within PC-ECG 1200 1. Record a rest study and apply the MATLAB function under the File menu. A file with extension LIB is created in the default data folder. The file has the following structure:

10,000 bytes X 12 Leads (I, II, III, AVR, AVL, AVF, V1, V2, V3, V4, V5, V6);

1sec = 1000 bytes = 500 samples. 2. Start Matlab (not included in PC-ECG software) and perform the required operation. NV-54/PCECG1200W 40 Instructions for Use and Technical Description Example of ECG Display with MATLAB 1. Open a file: handle = fopen('c:\default_\ patient_name.lib,'r') 2. Choose from which lead and which second to display the ECG:

fseek(handle, (Lead-1) * 10000 + (Sec-1) * 500,-1) where Lead (1,2,3,...,12) and Sec (1,2,3,...10) For example, if lead AVR (number 4) from the second 3 is requested:

fseek(handle,3*10000+2*500,-1) t = fread(handle, [sec * 500 ,1], 'int16') where sec(1,2,3,4,...,10) 3. Type: plot(t) The graph is displayed. Norav Medical Ltd. Stress ECG 41 CHAPTER 8: STRESS ECG

(This option is available with S0, S1, and S2 licenses) Multiple lead display Selected display: ST trends, 12 averages, Single QRS (current) Numerical display Enter blood Separating pressure bars Current protocol HR/BP trend Figure 8: Stress ECG Results Screen To Customize the Display Click and drag the separating bar between two sections with the mouse cursor. To Lock Screen Window Borders If you want to keep the display in its present format:

1. Click Setup > View tab. 2. Check Lock Splitter. NV-54/PCECG1200W 42 Instructions for Use and Technical Description Quick Start To Perform a New Test 1. Click F1 (or the New button on the toolbar). 2. Insert patient details in the dialog box. 3. Click OK. The preliminary Rest phase begins. 4. Click F3 (or Stress button) to start the Stress phase. 5. Insert blood pressure and/or remarks (if relevant) in the dialog box and click OK. 6. Click F5 (or Recovery button) to begin the Recovery phase. 7. Enter blood pressure and/or remarks (if relevant) in the dialog box and click OK. 8. Click F4 (or Stop button) to stop the test. To Print an ECG 1. Select Print ECG from File menu. 2. Select Current Stage\Entire Study from the Print ECG submenu. 3. Select the printer from the print dialog box. 4. Click OK to close the dialog box and start printing. To Print a Report 1. Click Print on the toolbar. 2. Select the report/s to print. 3. Click OK to start printing to the default printer. Or 1. Select Print Reports item from the File menu. 2. Select the report. 3. Define the printer in the Print dialog box. 4. Click OK to start printing the report. For an example of a printed report, see Appendix C: page 111. Norav Medical Ltd. Stress ECG 43 Leads Placement You can place the leads on the patient in various ways. The usual method is to place the leads in the standard positions on the chest (V1-V6). To identify the placement of the leads, the channels are renamed. One option for standard lead placement is V7-V9. Another is the Right chest Lead system. To Define the Lead System 1. Click Setup > Lead. 2. Select the lead system to use (the default is Standard). Operation with Function Keys F1 F2 F3 F4 F5 F6 F7 F8 F9 F10 F11 F12 New recording Run/stop pre-test monitoring Begin stress test Stop test Begin Recovery phase Set Event Freeze stage Next stage Manual control Previous stage Open saved study Stop treadmill or ergometer in emergency Table 9: Stress Function Keys Before using the stress test package define preferred parameters in Setup. Otherwise the program will operate according to the factory setup. N o t e NV-54/PCECG1200W 44 Instructions for Use and Technical Description Toolbar Overview Main Toolbar (Easy Toolbars Mode) This toolbar is displayed at startup. Use it to open an existing test or to begin a new one. New Change protocol About Open saved study Setup Figure 9: Main Stress Toolbar Stress Test Commands This toolbar is displayed at the start of a new test. Run/stop pre-test monitoring Set event Manual control Add remarks Begin recovery Previous stage Zoom heart rate Setup Begin stress test Stop test Freeze stage Next stage Emergency stop treadmill Figure 10: Stress Test Commands Toolbar Norav Medical Ltd. Stress ECG 45 Views and Filters Toolbar The toolbar controlling views filters appears beneath the main toolbar. Select leads to display Select filters Select horizontal/vertical scale Display next leads Display ECG only Figure 11: Stress ECG Views and Filters Toolbar Average Viewer Toolbar The toolbar displaying various post processing views appears to the right of the Views and Filters toolbar. Select leads to display Display QRS Select next leads Figure 12: Stress ECG Post Processing Display Toolbar NV-54/PCECG1200W 46 Instructions for Use and Technical Description Post Processing Options Toolbar When the test is complete you can review it using the Post Processing Options Toolbar. Open saved study Print results Add remarks Display next leads Display ECG test in new window Play current event Save results Show patient details Setup Display stages/events as table Skip to previous event Skip to next event Figure 13: Stress ECG Playback Toolbar Norav Medical Ltd. Stress ECG 47 Stress ECG Setup Printer Definition:

Printer definition is very important because of the high data rate during real time printing. If the printer has about 810 MB RAM, set the graphic resolution at 600 dpi. If the printer has about 2 MB RAM, reduce the resolution to 300 dpi. Click Setup on the Toolbar to access the following parameters:

Tab & Secondary Tab Option Description ECG Recording Default filters Defines the filters initial status in ECG recording. Save format Defines the amount of data to be saved on the disk. Save Options Auto Save Select this option to save the ECG test automatically at the end of the test. The test will be saved into the defined directory or to the database (if used). Set File Name by To add the Patient ID or Patient Last Name to the file name, select the required option. Simulator ECG Alert Signal OFF When cleared (default), ECG recording is performed from the PC-ECG unit. When checked, the ECG recording is performed from the demo file included in the software package. In this case, the recording unit is not needed. There is an alert (beep) when reach the target\warning zone of HR. If this option is marked, there is no alert. Beep on QRS When marked, beep is heard every time QRS is detected. ECG Leads Use ECG Database Data Directory When using the standard 12 lead patient cable, select the 12 Leads option to read and display up to 12 leads (default). When using a 6 lead cable, select the 6 Leads option to read and view up to 6 leads. Select this option to connect to the default ECG database. If this option is selected (checked) the ECG tests are saved in the database. Allows the user to define a directory for saved ECG recordings (if ECG database is not used). Use a secondary hard disk, if one is available. Define the 3 leads that are displayed as default when using 3x1 view format. Lead Systems Default 3 leads View Default 6 leads Define the 6 leads that are displayed as default when using 6x1 or 3x2 view format. Strip Lead 10 sec lead to appear in 4x3 and 6x2 formats. Count Recovery Time Separately from Stress Check this option to have separate times for the Stress phases and the Recovery phases. Clear this option to have the time displayed on screen (in Real time and in Review Screen) as the overall test time including the Stress and the Recovery phases. NV-54/PCECG1200W 48 Instructions for Use and Technical Description Tab & Secondary Tab Option Description Default Colors Default ECG View To define the default colors for background, traces, grid, light grid, text, and base average, click the appropriate button and select the color from the color palette. To restore the default colors click Restore Default in the frame. Select the default on screen lead display from the list in the combo box. When 6 Leads is defined in the ECG Recording tab, the maximum view is 6 leads. Easy Toolbar mode Check this option to display fewer icons. Text Labels Check this option to add text labels to the toolbar buttons. Separate Leads Check this option to have the leads separated by borders. Clear this option to have the leads not separated by borders. Draw over Leads Border Check this option to have high signals (exceeding the channel display) drawn beyond the lead border. Draw Grid Cabrera Display Lock Splitter Horizontal scale Vertical scale Ergometer METS/Watt Clear this option to have high signals cut off. Check to display grid lines. Uncheck to hide gridlines. Check this option when using a Cabrera lead system. When using the standard LEDs system, clear this option. When this option is checked, the splitters cannot be moved and the sections in the viewer cannot be resized. To resize the different sections in the viewer, clear this option. Sets the default value for the horizontal scale window on screen

(mm/sec). Sets the default value for the vertical scale window on screen

(mm/mV). Applies to an Ergometer test. The selected units (METS or WATT) are displayed for the Workload on the Review Screen

(post-processing). Saves user data (hospital and physician). This data is recorded on any print out and sent as email. Installation Measurement Standard Define whether measurements are calculated according to the metric or the USA standard. The default is metric. Magnetic Card Reader Select this option to use a magnetic card with bar-code to insert patient details. Select the magnetic card type. Environment Connection Display Size If an automatic blood pressure monitor (Tango) is to be connected to the system, checks for the appropriate COM port. Choose between 14/15-inch screen (default) and 17-inch screen. This setting is required in order to display the ECG and grid in the correct scale. Measure BP by Automatic Device If a blood pressure monitor is used, define whether automatic measurements should be performed in addition to manual measurements. Automatic BP COM Port Set the COM Port that the BP device (optional) is connected to. Exercise Device COM Port Select the COM port that the exercise device is connected to from the list. Norav Medical Ltd. Tab & Secondary Tab Option Advance Cards USB Stress ECG 49 Description R wave trigger (requires D1-t board) should be ticked if a blood pressure monitor is used or if external synchronization is needed. If analog out (requires D/A board) for metabolic or exercise device control is needed, select the appropriate options. The software is compatible with a metabolic chart manufactured by Ganshorn, Germany. Check R wave trigger option (when using USB connection with BNC output) if a blood pressure monitor is used or if external synchronization is needed. Select the required R-wave trigger width from the option list. Check ECG option for analog ECG signal. Use Transfer file Trnsf.txt Check this option to use Trnsf.txt file (see page 58). Exercise device Type Set up for PC-ECG connection, the external device (treadmill or ergometer) connection, and type. The factory default setup for the external device type is "None". In this mode, the software does not control an external device. Define the type of ergometer or treadmill that is being used. Exercise Device Default protocol Valid for S1, S2 options. Choose one of the available protocols or define your own protocol. Exercise Device Speed unit Set up for MPH or KPH. This option refers to treadmills only. Exercise Device Emergency STOP Metabolic Card Control Metabolic Card Control Select the procedure for Emergency STOP. Select Immediately for abrupt stop of the treadmill or Slow Down for gradually slowing down the treadmill until final stop. Check this option to control an external metabolic testing device for blood gas content. If this option is cleared (default) no communication is made with the metabolic testing device. Metabolic Card Manufacturer Select the metabolic card manufacturer from the list. Auto Print (Print Report) Check this option to print the metabolic test report automatically at the end of the test. Printouts Auto Print Default Reports on End Test Check this option to automatically print the default reports at the end of each test. Default Reports Define the default reports. Paper Size for ECG Printing Set paper size, either conventional printer or 4-inch thermal printer. Use Large fonts for Remarks Enables large font for user entered free text. Shadow/Frame for Area of Interest Allows the user to choose between shadow and frame to highlight the area of interest . Load Printer Drivers Ahead Check this option to save time by reading the driver before sending the print action. ECG Line Event Format Define the line width in the printouts, either Normal or Bold. Set Event format for printout to either 3 lead or 12 leads format. NV-54/PCECG1200W 50 Instructions for Use and Technical Description Tab & Secondary Tab Option Description Tabular Results Format Check this option to print out results in a tabular format. Graph Paper When set to On, prints 1mm and 5 mm squares on printouts. Regular Grid works with any printer. Improved Grid shows a fine grid but may not work on some printers. Color printout Select this option for colored printouts. Blending out ST values Select this option to print results without ST values. GDT/BDT Format Automatic Options Setup automatic options for saving and/or importing files in GDT/BDT format. File Format Select the file format: GDT or BDT. Import Codepage 437 Check this option to import Code page 437. Export Codepage 437 Check this option to export Code page 437. Edit Labels Click this button to open a dialog box with an editable list of the field labels used in the GDT and BDT files. GDT/BDT Data Directory Define the directory path where the GDT/BDT files should be maintained. Token for PCECG The default is PEKG. Token for Practice EDP The default is EDV1. Text File Auto Save Test Data in Text File Check this option to save the test data automatically to a text file at the end of the test (according to the naming and directory defined in this tab). Set Text File Name by Define the naming convention of the text file, created automatically or on demand. Text File Data Directory Define the directory where the text files will be maintained. Target HR/METS Target HR Target HR warning zone %

Stop Stress and start Recovery Set the maximum male and female HR for to be allowed for use in the Target HR equation . The target HR is affected by the age of the patient. Set the percentage of target HR for warning. Above this level, the HR trend is displayed in a different color. If the percentage value is reached during the test and Switch to Recovery when reaches HR Warning zone option is checked, the stress test stops automatically and recovery phase begins. Check this option to stop stress test when HR reaches the target HR or warning zone and start the recovery phase. When Switch to Recovery when reaches HR Warning Zone" is cleared, the Stress test continues according to the test protocol. METS/VO2 Formula selection Set the formula to calculate the METS/VO2 values:

To use a single formula check single formula for any speed. To use one formula for speed up to 3.7 m/h and a second formula above that speed, set the option Two formulas (Up to and from 3.7 m/h). Norav Medical Ltd. Tab & Secondary Tab Option METS/VO2 Updating Method Stress ECG 51 Description Select the method for updating the METS/VO2 values. The values can:

remain constant through the entire stage switch to the current METS value 1 or 2 minutes after the stage begun have values vary during the stage (at every quarter of the stage time). ST.VPB Options ST Measurements After J Detect ST Event Real Time Printing Choose the number of milliseconds after the J point at which the ST is measured. The factory set up is 60 Ms. Define the mm level for elevation and depression. This option also allows the user to save only deteriorated ST episodes. Set the events to print (including ST/VPB/SVPB). Any checked event will be printed. Cleared events will not be printed (9 events). Show Dialog Check events to display a dialog box at the beginning. Clear events to prevent display of dialog box. Print Page Format Check the required option for printout format. Print Scale Format Select the scale for printout format. St, Slope Printing Select this option to print the ST and ST slope values. Clear to prevent printing. Switch to Review Automatically Check this option to switch automatically to the Review screen at the end of the test. When cleared, the realtime screen remains Remarks Remote View Defines statements that can be entered during the test. It is divided into five sets of statements used during real time and post processing. Valid for option S2. Enables viewing a study that takes place in any of the network stations, across the whole network. Enables a physician to view a study remotely. Table 10: Stress ECG Setup Options NV-54/PCECG1200W 52 Instructions for Use and Technical Description Toolbar and Menus: Main Click this icon To do this Start a new study Open an existing study Save a recording Print results Recover file to Monitoring format Import demographic data from HIS to PC-ECG Export the GDT/BDT file from PC-ECG to HIS Create a text file Restore default window size Set/change patient data Add/view remarks Select a different protocol Set preferences To display information Or use this short-cut key F1 Or select this menu Description File > New Creates a new study F11 File > Open Opens an existing study Ctrl+S File > Save Saves the active study Ctrl+P File > Print Report or Print ECG Prints the active study File >

Recovery File to Monitoring Format File >

GDT/BDT Format For details see Import from GDT/BDT, page 105 File >

GDT/BDT Format For details see Save Test in GDT/BDT page 105 File > Create Text File View > Set Default Window Size Enables saving and viewing data if the Stress application crashes. Select this option in the main frame. In the dialog box, provide a name and path for the file (*.TMP). To view the ECG open this file with the Monitoring application (main frame menu). This file always contains the last patient data. This file always contains the last patient data. Saves ECG data in text format. Restores the default window size of the sections in the window. (Available in realtime) View > Patient Sets or changes patient data Ctrl+R View >

Remarks View >

Change current protocol Allows you type free text during or after the ECG recording. It is printed and saved together with the ECG traces. Changes the protocol Ctrl+T View > Setup Displays the setup dialog box Help > About Stress Displays program information, version number, and copyright Table 11: Main Stress Toolbar and Menus Norav Medical Ltd. Stress ECG 53 Toolbar and Menus: Stress Test Commands To do this Start/stop monitoring Start stress test Start recovery phase Stop test/recovery phase Set an event Measure blood pressure Freeze the current stage Return to the previous protocol stage Advance to the next protocol stage Control the exercise device manually Stop the treadmill or ergometer in an emergency Display enlarged heart rate Display study results Click this icon Or use this short-cut key Or select this menu Description F2 F3 F5 F4 F6 F7 Test >

Run/stop monitoring Test > Stress test begin Test >

Recovery begin Test > Stop test Test > Set event Test >

Measure BP Test > Freeze stage Runs/stops monitoring Starts stress test Starts recovery phase Stops stress test or recovery phase Sets events and prints according to options Activates the blood pressure monitor Freezes the current protocol stage F10 Test >

Previous stage Returns to the next protocol stage F8 F9 Test > Next stage Test > Manual management Advances to the next protocol stage Manually controls the exercise device F12 Test > Stop exercise device Emergency stop for treadmill or ergometer Ctrl+H View > Zoom up heart rate Enlarges display of heart rate window Test > Review Displays study results Table 12: Stress Test Commands NV-54/PCECG1200W 54 Instructions for Use and Technical Description Toolbar and Menus: Average Viewer To do this Click this icon Description Display 3 lead average Display 12 lead average Display single QRS Scroll between lead displays Display QRS Averages of 3 leads and ST trends 12 leads averages Single QRS Double function:

a) scroll for all leads in the 3X1 display b) point to the requested lead Base line QRS in white and current QRS in yellow Table 13: Average Viewer Toolbar Toolbar and Menus: Post Processing

(Right hand side of tool bar) To do this View 12 leads ST trends results View 3 leads ST trends results View next ST trends Triplet View numerical results Undo the last action View ECG 10 sec data Move marker to previous event Move marker left 10 sec Play back results Move marker right 10 sec Move marker to next event Add (create) a new event Delete the current event Click this icon Or use this short-cut key Or select this menu View > 12 Leads ST View > 3 Leads ST View > Next ST Leads Ctrl+V View > Properties Ctrl+Z Enter View > Open ECG Data (requires I1 or I2 license). Ctrl+

View > Event > Previous Event

View > Event > Left View > Play ECG Data View > Event > Right Ctrl+

View > Event > Next Event View > Add New Event View > Delete Current Event Norav Medical Ltd. Stress ECG 55 To do this Set preferences Print the study Position the ST marker Click this icon Or use this short-cut key Or select this menu Ctrl+T View > Setup File/Print ECG This enables you to print the entire study or a single stage View/Rec alculate ST This enables you to position the ST marker for the entire study Table 14: Post Processing Toolbar and Menus To Start the Stress Recording Program Double click the stress icon. The initial screen is displayed. To Start a New Test 1. Define the exercise machine (Treadmill/Ergometer). (See page 49.) 2. If necessary, click the Change Protocol icon protocol. to select a test Figure 14: Change Test Protocol 3. Click the white page icon. The Stress working screen and patient data entry screen are displayed. NV-54/PCECG1200W 56 Instructions for Use and Technical Description Figure 15: Patient Data Entry 4. Enter patient data and click OK. Monitoring of 12 leads begins. After about 15 sec the average QRS is displayed. 5. Inspect the protocol label in the lower right hand corner. To choose another protocol, click the Change Protocol icon (or select View >

Change Protocol), select the requested protocol, and click Change. 6. Enter blood pressure for rest. You can print a Rest printout using the EVENT icon multiple Rest printouts. without starting the Stress program. This enables 7. To start the stress session, click the Stress icon (running man). The stress time is displayed in the lower left-hand corner. The following options are available:

Define events Go to Manual Freeze Stage Advance Stage Go to Recovery phase. Recovery Phase When you switch to recovery phase, the recovery phase elapsed time is counted as well as the total elapsed time. Wait for recovery phase to finish according to protocol or stop it using the stop icon. Both TEST time and RECOVERY time are fixed. Patient monitoring continues. Click and disable Go to stop it. Viewing Results There are two options for completing a stress test. Display the post-processing data screen (Review Screen) automatically Remain in ECG display. Norav Medical Ltd. Stress ECG 57 To View Study Results Click the Post Processing icon. This enables display and printout of the entire study. Note that before saving the study to disk, the entire ECG is kept for review. To Display the Review Screen Automatically In Setup, click the Real-Time tab and check Switch to Review Automatically. At the end of the test protocol, or after clicking F4, the display switches automatically to the Review Screen, and the post-processing information is displayed. To Display the Review Screen Manually If Switch to Review Automatically is not enabled:

1. Click F4 The test (exercise device) stops but the ECG signal continues to run. 2. Click F2 The ECG signal stops and a Review button is displayed on the tool bar.

(The Review button is not displayed if Switch to Review Automatically is enabled). 3. To review the post-processing information, click Review. The Review Screen is displayed with the post processing data. It provides the following options:

Print reports automatically. Save and display ORIGINAL Data with real time filters (with removal option). Print All Events in REVIEW. Print on an additional page if necessary. Print ST Measurements optionally. To Save Study Results 1. Click Setup > ECG Recording. 2. Select options for saving the study and click OK. 3. Click File > Save, define the file name and path, and click OK. NV-54/PCECG1200W 58 Instructions for Use and Technical Description Metabolic Stress Estimation (METS) A very important feature of the software is the estimation of Metabolic Equivalency

(METS). This estimates how many ml of oxygen the body produces for every kg of weight per minute. The results are shown in units of METS or VO2 Max. (One unit of VO2 is 3.5 units of METS.) 1 METS corresponds to a person at rest. A higher METS indicates a higher fitness level. Transfer File Trnsf.txt Use this option when the PC-ECG 1200 shares the same PC with another application in real time. To Transfer a File 1. Click Setup > Environment. 2. Click the Advance tab. 3. Check Use transfer file TRNST.TXT A transfer file is created in the directory containing the Stress application file. The default is C:\Program Files\Pc-ecg. The transfer file receives real time data from the Stress application, such as: current Heart Rate, Workload, Speed, and Grade of external device. It is a text file, updated every 5 seconds. The format is as follows: Each text line starts with a descriptive header and a parameter that always starts at character number 13. The value of each parameter may change during the study. Parameter Current Value Range (not included in text file) HR :

86

(0-200) Speed(mph):

3.3

(0- 25) Grade(%) :

1.0

(0 30) Workload :

10.1

(0 1000) Table 15: Transfer File Format A Sharing Violation error may occur if the file is read while the Stress Application is updating it. Wait until updating is completed (a second or two). N o t e Norav Medical Ltd. Stress ECG 59 Additional Features To Define Max. HR 1. Open a test in a Review Screen (post processing). 2. Click Properties on the toolbar The Properties dialog box is displayed. 3. Select the cell with the highest HR value. 4. Click Define Max HR. The cell is highlighted and the background color of the cell is changed. To Define Worst ST 1. Open a test in a Review Screen (post processing). 2. Click Properties on the toolbar The Properties dialog box is displayed. 3. Select a cell in one of the channels with the worst ST. 4. Click Define Worst ST. The cells in the 12 channels of the same event are highlighted and the background color is changed. NV-54/PCECG1200W 60 Instructions for Use and Technical Description RS232 Controlled Treadmill Types Vendor Model Vendors Fax RS232 Connector on the TM RS232 Wiring Type Trackmaster TM425

+1-316-283-3350 D-9 female Trackmaster TMX425

+1-316-283-3350 D-9 female Parker RAM Woodway Powerjog PM 770

+1-334-8213221 D-9 female

+39-049-8703388 D-9 female PPS55-MED D-9 male Crossed GM, J

+44-121-4333035 System Biomedical

+91-22-4963147 HP COSMOS All models

+49-8669-864249 QUINTON QUINTON TM-55 ST-55 Marquette 2000 series Straight Straight Straight Straight D-9 female Straight D-9 female

(RS422) D-9 female

(RS422) DIN 5 pin female Q422*

M422*

Tx 5 Rx 4 GND - 2 KIP Machines KIP Series

+5411-4327-2963 DB9 Male BONTE MACHINEFABRI EK B.V.

+54341-464-7302

+54341-463-7919

+ 31 038-4554030 DB9, crossed Lines: RX, TX, GND standard place in DB9 Male connector Treadmill (SUB-D 25)

<----> PC (SUB-D 25) 2 ---------- 3 3 ---------- 2 7 ---------- 7

* Requires a special adaptor, supplied by Norav Medical Table 16: Controlled Treadmills Norav Medical Ltd. Stress ECG 61 RS232 Controlled Bicycle Ergometers Vendor Model Vendors Fax RS232 Connector on the Ergometer RS232 Wiring Type Ergoline SECA Dimeq LODE ER900 CT100 770 EXCALIBER ELMED

+49-7431-989427 DIN 5 pin

+49-40-20000050 D-9 male Crossed

+49-30-72376240 Table 17: Controlled Ergometers NV-54/PCECG1200W Late Potential Signal Averaging 63 CHAPTER 9: LATE POTENTIAL SIGNAL AVERAGING

(This option is available with the L1 license) Signal averages Filtered averages Vector magnitude Numerical results Heart trends Figure 16: Late Potential Signal Averaging Screen NV-54/PCECG1200W 64 Instructions for Use and Technical Description Quick Start To Start a New Test 1. Click F1 (or the New button on the tool bar). 2. Insert patient details in the dialog box. 3. Click OK. 4. Click F3 or F4 to start the LP averaging test. 5. Enter the interval name and/or remarks as appropriate in the dialog box and click OK. 6. Click F3 or F4 (or Start/Stop Averaging button) to stop the LP averaging test (or wait until it terminates). To Print 1. Click F6, or select Print item from the File menu. 2. Select the printer from the Print dialog box. 3. Click OK to close the dialog box and print the display (the LP averaging report or the ECG test). Norav Medical Ltd. Late Potential Signal Averaging 65 Operation with Function Keys F1 New recording F3/F4 Start/stop F6 F11 Print Open saved study Table 18: LP Signal Averaging Function Keys For an example of a printed report, see Appendix C:, page 111. Leads Recording is performed for leads X, Y, and Z (orthogonal) using the regular 12 lead cable. Arrange the leads as follows:

12 Lead Orthogonal Lead (position) V2 V1 V4 V3 V6 V5 X+ left side of the chest X- right side of the chest Y+ lower side of the chest Y- upper side of the chest Z+ middle of the chest Z- middle of the back RA,LA,LL,RL Same position as in 12 leads Table 19: LP Signal Averaging Leads Placement NV-54/PCECG1200W 66 Instructions for Use and Technical Description LP Signal Averaging Setup Click Setup on the Toolbar to access the following parameters:

Tab ECG Recording Option Description Auto Save(Save Options) When Auto Save is ON, the file is stored by Last name or by ID. When Auto Save is OFF, the program requests a filename. Set File Name by (Save Options) Set the naming convention for saving files (by Patient Last Name or ID) Simulator ECG When cleared (default), ECG recording is performed from the PC-ECG unit. If checked, the ECG recording is performed from the demo file included in the software package. The recording unit is not required. Stop to confirm QRS When ON, the user can choose the Normal QRS. When OFF, the program chooses the Normal QRS automatically. Template Correlation Defines the QRS percentage match during signal averaging. A higher number corresponds to a better match. Target Number of Beats Number of typical heartbeats that will be counted during the averaging stage. Use ECG Database Check this option to connect to the default ECG database. ECG tests are saved in the database. Data Directory Defines the directory for saved ECG recordings. View ECGs Colors Averages Color HR Trends Color To modify the ECG colors, click the appropriate button and select the color from the color palette. To modify the colors in the Averages window, click the appropriate button and select the color from the color palette. To modify the colors in the HR Trends window, click the appropriate button and select the color from the color palette. Restore Defaults Click to restore the default factory colors Installation Saves hospital and physician data. This data is included in print out and email. Measurement Standard Define whether measurements will be calculated according to the metric or the USA standard. The default is metric. Magnetic Card Reader Select this option to use a magnetic card with bar-code to insert patient details. Select the magnetic card type. Norav Medical Ltd. Late Potential Signal Averaging 67 Tab Option Description Environment Connection Use the option button (COM port/USB) to select the port for device connection. If COM port is selected, select the serial input for the PC-

ECG unit from the COM port list. If the USB connection is selected, the COM PC-ECG selection list is disabled. (Default at installation is USB). Graph paper If ON, prints 1mm and 5 mm squares on printouts. Regular grid prints from all printers. Improved grid shows a fine grid but may not work on some printers. Use Large Fonts for Remarks Enlarges font for free typed text. Color printouts Clear this option to force B/W printing on color printer. Display Size Choose between 14/15-inch screen (default) and 17-inch screen. This setting is required in order to display the ECG and grid in correct scale. GDT/BDT Format Automatic Options Define automatic options for saving and/or importing files in GDT/BDT format. File Format Select the file format: GDT or BDT Import Codepage 437 Check this option to import Code page 437. Export Codepage 437 Check this option to export Code page 437. Edit Labels Click this button to open a dialog box with an editable list of the field labels used in the GDT and BDT files. GDT/BDT Data directory Define the directory path where the GDT/BDT files will be maintained. Token for PCECG Default is PEKG. Token for Practice EDP Default is EDV1. Holter File Path Download Flash Card Program Define the path for the flash card program directory. Download Directory Define the directory to maintain the downloaded Holter files. Table 20: LP Signal Averaging Setup NV-54/PCECG1200W 68 Instructions for Use and Technical Description Toolbar and Menus To do this Click this icon Or use this short-cut key Or select this menu Description Start a new study Open an existing study Save a recording Send data via email Print results Import demographic data from HIS to PC-ECG Export the GDT/BDT file from PC-ECG to HIS Set/change patient data Add/view remarks F1 File > New Starts a new XYZ recording. The patients demographic data can be entered prior to ECG recording (optional). The three channels are displayed on the screen for quality assurance. If the results are unsatisfactory, check skin preparation and disposable electrode contacts. Then click Start/Stop Averaging. F11 File > Open Opens an existing study Ctrl+S File > Save Saves recording to disk (default file name: REST). File >Send... Sends recording data via email, if present on the computer. F6 File > Print Prints the active study File >

GDT/BDT Format For details see Import from GDT/BDT, page 105 File >

GDT/BDT Format For details see Save Test in GDT/BDT page 105 View >

Patient Data This file always contains the last patient data. This file always contains the last patient data. Adds this data to the recording. It is printed together with the ECG traces. If the recording is saved, then the PATIENT DATA is saved together with the ECG traces. Use the Previous option if the same patient undergoes a second study. View >

Remarks Allows you type free text during or after the ECG recording. It is printed and saved together with the ECG traces. Norav Medical Ltd. Late Potential Signal Averaging 69 Click this icon Or use this short-cut key Or select this menu Description Ctrl+T View >

Setup Displays the setup dialog box and allows the user to tailor operation preferences. Help >

About Displays software version number (which should be quoted on any inquiry regarding the software). Also displays memory size and disk free space. F3/F4 ECG >

Start/Stop Averaging Allows the user to start the averaging period. The averaging period default is 200 beats. It can be changed in OPTIONS, ECG RECORDING, and TARGET NUMBER View > Grid Optional display of 5mm raster. Print outs are always with 1mm raster. F2 F2 ECG >

Start/Stop Monitoring ECG >

Start/Stop Monitoring Starts monitoring. Stops monitoring. Ctrl+

ECG Onset marker Allows the user to move the Onset Marker using the direction arrow icons. Ctrl+

ECG Offset marker Allows the user to move the Offset Marker using the direction arrow icons. Allows the user to move the ON/OFF markers.

Table 21: LP Signal Averaging Toolbar and Menus NV-54/PCECG1200W To do this Set preferences To display information Start/Stop Averaging Display/Hide the grid Start monitoring. Stop monitoring Activate Onset Marker Activate Offset Marker Move the On and Off markers 70 Instructions for Use and Technical Description Interpreting Results When the signal-averaging phase is complete, the result screen is displayed:

Numerical results Figure 17: LP Signal Averaging Review Screen Norav Medical Ltd. Late Potential Signal Averaging 71 Numerical Results Averaged Beats Displays the number of averaged normal beats captured during the study. HR Average in beat/min High Frequency QRS Duration in Milliseconds from ONSET to OFFSET Displays the width of the filtered QRS containing only high frequencies. A higher number indicates higher patient risk. RMS LASTS 40 milli-

seconds in Microvolts Displays the total activity for the last (40ms) portion of the QRS. A lower number indicates higher patient risk. DURATION UNDER 40 Microvolts in Milliseconds Shows the period in ms from offset of the QRS till the first point of 40uV activity. A higher number indicates higher patient risk. H.F. Noise: in Microvolts Quality assurance. A lower number corresponds to higher result accuracy. The maximum number should not exceed 1 V. Table 22: LP Signal Averaging Numerical Results The results are calculated automatically. You can overrule the automatic positioning of the ONSET/OFFSET markers with the direction keys. NV-54/PCECG1200W Instructions for Use and Technical Description 72 Norav Medical Ltd. Monitoring 73 CHAPTER 10: MONITORING

(This option is available with the M1 license) This option enables long-term recording and storage to disk. The user decides which leads and at which sample rate to monitor on screen and save to disk. During the study, you can print in real time on a thermal printer. Toolbars Horizontal scale

(mm/sec) Vertical scale

(mm/mV) Heart rate

(beats/min) Slider time Total study time Figure 18: Monitoring Screen NV-54/PCECG1200W 74 Instructions for Use and Technical Description Quick Start To Start a New Test 1. Click F1 (or the New button on the tool bar). 2. Insert patient details in the dialog box. 3. Click OK. 4. Click F2 (or Start/Stop button) to stop data collection or wait until end time. To Print 1. Click F6, or select Print item from the File menu. 2. Select the printer from the Print dialog box. 3. Click OK to close the dialog box and print the display. Print Study (print a selected time range and leads) 1. Click Print Study on the toolbar or select Print Study Item from the File menu. 2. Define the time range and select the leads to print from the dialog box. 3. Click OK to acknowledge selection and close the dialog box. 4. Select the printer in the Print dialog box. 5. Click OK to start printing. Monitoring ECG Setup Click Setup on the Toolbar to access the following parameters:

Tab Sample Rate\Leads Selection Option Description Leads Allows the user to select leads. To select all leads, click Select All. To deselect all leads click Unselect. Sample rate Allows the user to choose requested samples per second per channel. X,Y,Z Check this option to monitor X, Y, and Z axis. Clear the option to select the other leads to be displayed and monitored on screen. With this option, monitoring other leads is not possible

(default is cleared). Norav Medical Ltd. Monitoring 75 Tab Option Description 12 Leads View Default 3 leads This function is available only if 12 lead monitoring is selected. 3 leads appear if 3X1 format is used. Strip Lead 10 sec. lead appears in 4X3 and 6X2 formats. ECG recording Filter 50/60Hz When checked, the default status of 50/60Hz filter is ON

(according to the checked frequency 50 or 60). Default is cleared. EMG Filter When checked, the default status of the EMG filter is ON. Default is cleared. Baseline filter When checked, the default status of the Baseline filter is ON. Default is cleared. Save options If Auto Save is ON the file is stored by last name or by ID. If Auto Save is OFF the program requests a filename. Simulator ECG ECG Recording time

(h:m) Data Directory If cleared (default), ECG recording is performed from PC-ECG unit. If checked, ECG recording is performed from the demo file included in the software package. The recording unit is not needed. Determines study duration in minutes. Defines the directory for saved ECG recordings. Use secondary hard disk if available. If checked (default), does not limit the extreme high amplitude ECG pulses from exceeding the borders. If cleared, chops the pulses at the borders. View Draw Over Lead Borders Horizontal Scale Sets the default value for the Horizontal scale window on the screen. Vertical Scale Sets the default value for the Vertical scale window on the screen. Slider step size Off line function. Sets the default value for slider steps when moved by mouse or arrow keys. Colors Restore Defaults Allows the user to choose colors. Restores factory defaults. Installation Saves hospital and physician data. This data is included in print out mail. Measurement Standard Define whether measurements will be calculated according to the metric or the USA standard. The default is metric. NV-54/PCECG1200W 76 Tab Instructions for Use and Technical Description Option Description Magnetic Card Reader Select this option to use a magnetic card with bar-code to insert patient details. Select the magnetic card type. Environment Connection Select the option button (COM port/USB) to choose the port for device connection. If the COM port option is selected, select the serial input for the PC-ECG unit from the COM port list. Disabled if the USB connection is selected. (Default at installation USB) Display Size Choose between 14/15-inch screen (default) and 17-inch screen. This setting is required to display the ECG and grid in correct scale. If set to On, it prints 1mm and 5 mm squares on printouts. Graph paper Regular Grid is guaranteed to fit any printer. Improved Grid shows a fine grid but may not work on some printers. Large Remarks font Enlarges printed text. Color Printout Forces B/W printing on color printer. Thermal Plotter Sets LPT port for optional thermal paper. GDT/BDT Format Automatic options Setup automatic options for saving and/or importing files in GDT/BDT format. File Format Select the file format: GDT or BDT Import Codepage 437 Export Codepage 437 Edit Labels Check this option to import Code page 437. Check this option to export Code page 437. Click this button to open a dialog box with an editable list of the field labels used in the GDT and BDT files. GDT/BDT Data directory Define the directory path where the GDT/BDT files will be maintained. Token for PCECG Token for Practice EDP Default is PEKG. Default is EDV1. Table 23: Monitoring Setup Options Norav Medical Ltd. Monitoring 77 Toolbar and Menus To do this Start a new study Open an existing study Save a recording Print results Export to Rest Export to MATLAB Import from ISHNE Plot in real time Set/change patient data Add/view remarks Set preferences To display information Click this icon Or use this short-cut key Or select this menu Description F1 File > New Test Starts a new monitoring session. Patient data can be entered prior to ECG recording (optional). The recording time is set in SETUP for ECG RECORDING. The user can stop recording by clicking the GO/STOP icon. F11 File > Open Shows recordings saved on disk. Ctrl+S File > Save Saves recording to disk. F6 File > Print File > Export to Rest Off line printing. Determine the time range to be printed. The acquired ECG is printed in miniature format horizontal: 6.25mm/sec and vertical: 2.5 mm/mV. A 10 sec segment containing original leads I,II,V1-V6 and calculated leads III, aVR, aVL, aVF is transferred into Rest format (up to 12 leads 10 sec). Calculated leads are performed only if I and II are acquired. File > Export to MATLAB A 10 sec segment containing acquired leads is transferred into MATLAB format. File > Import from ISHNE Long-term high resolution ECG recorded on Holter can be transferred into a monitoring study View > Patient data View >

Remarks Real time printing on a thermal printer. Can print continuously while monitoring up to 8 leads. Displays patient demographic information. Allows the user to enter free text during or after the ECG recording. This is printed and saved together with ECG traces. Allows the user to tailor operation preferences. Help >

About Software version number. Quote this for any software inquiry. Also shows memory size and free disk space. The HASP ID number is the ID of existing software keys. This ID number is used for adding software options. NV-54/PCECG1200W 78 Instructions for Use and Technical Description Click this icon Or use this short-cut key Or select this menu Description View > Grid Optional display of 5mm raster. F2 F2 Ctrl+1 Ctrl+2 Ctrl+3 Ctrl+0 ECG >

Start/Stop ECG >

Start/Stop View > Leads format >

Windows View > Leads format > All leads View > Leads format > Lead group View > Leads format > Next leads Starts ECG recording. Stops ECG recording. Classical format. Displays 12 lead ECG of 2.5sec ECG + 10sec trace.*

Displays 12 lead ECG of 10sec ECG.*

Displays 3 lead ECG of 10sec ECG.*

Allows the user to scroll through all leads in the 3X1 display ECG > Filters

> 50/60 Hz ON/OFF for line interference filter. Set OPTIONS for 50 or 60 Hz prior to operation ECG > Filters

> EMG ECG > Filters

> BaseLine ON/OFF for muscle noise filter ON/OFF for baseline filter on ECG data To do this Display/Hide the grid Start ECG Recording. Stop ECG Recording Display 3X4 Leads Display 12X1 Leads Display 3X1 Leads Display the next leads Set 50/60 Hz filter Set EMG filter Set base line filter Table 24: Monitoring Toolbar and Menus

* ECG data can be set up as limited amplitude or unlimited amplitude, which can cause one lead data to overlap a neighboring lead. Norav Medical Ltd. Heart Rate Variability (HRV) 79 CHAPTER 11: HEART RATE VARIABILITY

(HRV)

(This option is available with the H1 license) Time and frequency domain analysis is designed for short studies in which one or more time segments are measured, as in a Tilt study. Measured/reported parameters are according to NASPE/ESC Guidelines. Histogram P.S.D. Tachogram Slider HRV results NV-54/PCECG1200W 80 Instructions for Use and Technical Description Key:

Histogram The histogram relates to the active part (yellow) of the tachogram P.S.D. The power spectrum distribution Tachogram The tachogram trend shows all intervals. Each beginning of an interval is checked with a red line followed by the intervals name. To activate an interval, click it. To activate several neighboring segments, press SHIFT and move the slider. Slider Use the slider at the bottom to:

Define new intervals Change interval duration, and Activate several intervals HRV results The HRV results pane displays the results in numerical format. Table 25: HRV Screen Quick Start To Start a New Test 1. Click F1 (or the New button on the tool bar). 2. Insert patient details in the dialog box. 3. Click OK. 4. Click F3 or F4 to start the HRV test. 5. Enter the interval name and/or remarks as appropriate in the dialog box and click OK. 6. Click F3 or F4 (or the Start/Stop HRV button) to stop the HRV test

(or wait until it ends). To Print an HRV Report 1. Click Print on the toolbar or select Print from the file menu. 2. Select the printer from the print dialog box. 3. Click OK and the report is printed. For an example of a printed report, see Appendix C:, page 111. Norav Medical Ltd. Heart Rate Variability (HRV) 81 To Print an ECG 1. Click the Print ECG button on the toolbar or select Print ECG from the file menu. 2. Select the beats and leads to print from the dialog box and click OK. 3. Select the printer from the print dialog box. 4. Click OK to close the dialog and print the ECG. HRV Setup 1. Click the HRV icon. The HRV window is displayed. 2. Click the Setup icon (hammer). The following folders are displayed:

Tab Option Description Sample Rate\Leads Selection ECG Recording Leads Choose leads and sampling rate. Select up to four neighboring leads for calculations. Filters Set filters as active. Test Duration Define the test duration either by target number of beats or by the ECG recording time. Select the preferred parameter and define the value for the test duration. Save Options Set the Preferred saving options:

To save test automatically at the end of the test, check the Auto Save option. When this option is cleared, the test is saved only on demand. Define the saving format either as No ECG Data or Full Disclosure. Define the file naming convention of the saved files, either by Patient Last Name or ID. Use ECG Database Select this option to connect to the default ECG database. When this option is checked, the ECG tests are saved in the database. Data Directory Simulator ECG Define a directory for saved ECG recordings (if ECG database is not used). Use a secondary hard disk, if one is available. When cleared (default), ECG recording is performed from the PC-ECG unit. When checked, the ECG recording is performed from the demo file included in the software package. In this case, the recording unit is not needed. View Change default colors for ECG and for graphs. NV-54/PCECG1200W 82 Instructions for Use and Technical Description Tab Option Restore Defaults Description Restores factory default color definitions for ECG display and graphs. Installation Saves hospital and physician data. This data is included in print out and mail. Measurement Standard Define whether measurements will be calculated according to the metric or USA standard. The default is metric. Magnetic Card Reader Select this option to use a magnetic card with bar-code to insert patient details. Select the magnetic card type. Select the option button (COM port/USB) to choose the port for device connection. Environment Connection If the COM port option is selected, select the serial input for the PC-ECG unit from the COM port list. The option is disabled if the USB connection is selected. Default at installation is USB. Display Size Choose between 14/15-inch screen (default) and 17-inch screen. This setting is required to display the ECG and grid in correct scale. Graph Paper

(Print options) Large Remarks Font When set to On, prints 1mm and 5 mm squares on printouts. Regular Grid works with any printer. Improved Grid shows a fine grid but may not work on some printers. Enlarges font for free typed text. Color Printout Clear the check-box to force B/W printing on color printer. GDT/BDT Format Automatic Options Define automatic options for saving and/or importing files in GDT/BDT format. File Format Select the file format: GDT or BDT Import Codepage 437 Export Codepage 437 Edit Labels GDT/BDT Data directory Token for PCECG Token for Practice EDP Check this option to import Code page 437. Check this option to export Code page 437. Click to open a dialog box with an editable list of the field labels used in the GDT and BDT files. Define the directory path where the GDT/BDT files will be maintained. Default is PEKG. Default is EDV1. Norav Medical Ltd. Heart Rate Variability (HRV) 83 Starting a Study 1. Click New. 2. Enter patient data in the Patient Data field. The ECG leads are monitored on the screen for quality check. If you are satisfied with the quality check, click the R-R icon. The display comprises three sections:

The ECG leads are displayed on the upper part of the screen The tachogram trend display is built up in the middle strip. A slider shows the study status and time at the bottom During the study, define a new time segment (interval) by clicking the flag icon

(interval). Name each interval during the study to retain it as a valid interval. When all predefined beats are completed, or if terminated by clicking the R-R icon, the HRV screen is displayed:

To Add or Subtract an Interval 1. Select the interval with the slider. 2. Click + or at the top of the HRV results pane. To Edit Interval Names Use the pencil icon. To Import or Save GDT/BDT Format See Import from GDT/BDT and Save Test in GDT/BDT, page 105. NV-54/PCECG1200W 84 Instructions for Use and Technical Description Results Display The AVERAGE HEART RATE is displayed in the lower left side. All results are for the chosen segment (check the yellow selection or the From-To bits number). Other results are shown in the right hand side as follows:

RR no. max RR min RR Number of beats in the active interval Longest R-R period Shorter R-R period Average RR Average of interval in active interval Time Domain SDNN SDANN RMSSD Standard deviation of all R-R periods in interval Standard deviation of the averages of R-R periods in all 5 min segments of the active interval The square root of the mean of the sum of the squares of differences between adjacent NN intervals HRV triangular Index Total number of all R-R intervals divided by the height of the histogram of all R-R intervals measured on a discrete scale Frequency Domain ULF VLF LF HF Power of the ultra low frequency range Power of the very low frequency range Power of the low frequency range Power of the high frequency range Figure 19: HRV Results HRV Interval Measurement A QRS detector measures the interval between any two valid beats. It calculates a sliding N-N average and compares each interval to it. When a significant change occurs, the current beat is either a premature beat (as in PVC) or a prolonged one, which may indicate either a compensatory pause following a PVC or a missing beat. A premature interval and a following prolonged interval (compensatory pause) timed in the range of twice the current N-N interval are averaged. This methodology maintains a consistent time axis in the presence of PVCs. If a prolonged interval follows a normal interval, but at twice the current N-N interval, it indicates the presence of a missing beat. Accordingly, the missing beat is computed as present. This last event is very rare, because the recording is made in rest condition and the software detects the QRS efficiently under such conditions. Norav Medical Ltd. Measurements/ Interpretation 85 CHAPTER 12: MEASUREMENTS/

INTERPRETATION

(This option is available with the I1 or I2 license) Measurements is not an autonomous application. The Measurements application is used for calculations of QRSs and interpretation of the ECG signal. The user can manually change the QRS identification parameters. 10 seconds of data are calculated. Menu bar Toolbar Wave type Marker name Add/Remove ECG Wave Markers Figure 20: MeasurementsTabular Screen NV-54/PCECG1200W 86 Instructions for Use and Technical Description Quick Start To Start Measurements Click the ruler icon in the Rest, Stress, and Monitoring applications, or click View > Measurements The application has four view formats:

Measurements Table (default display) ECG Averages QRS Signal Caliper To Print Reports 1. Click the printer icon or select File > Print Reports. 2. Select the reports to print and click OK. Performing Changes in Calculations To Move the QRS Marker

(Averages and QRS views only) 1. Click and drag the marker to the required position (between the previous and next markers). 2. The calculations are modified accordingly. To Add or Remove a Wave Marker 1. Click the Add/Remove ECG Wave Markers icon on the toolbar

(or select File > Add/Remove ECG Wave Markers). 2. Check or clear wave markers in the dialog box displayed. 3. Click OK to save the selection, close the dialog box, and display the change. Norav Medical Ltd. Measurements/ Interpretation 87 To Move the Wave Marker

(Caliper view only) 1. Select a wave from the wave list on the left hand side of the viewer (or from the Wave Type combo box). 2. Select the marker from the Marker Name combo box in the toolbar or by clicking the marker. 3. Use the Left/Top/Right/Bottom arrows on the toolbar or drag & drop the marker to the required position. The calculations are modified accordingly. Features View all calculated parameters on every QRS, on every channel and average calculations in tabular format. The upper table displays measurements for a channel. The lower table displays measurements values for a QRS. To View the Measurements on a QRS Select a QRS from the upper table and view the results on the lower table. To View the Measurements on a Channel Select a channel from the lower table and view the values on the upper table. To View the Measurements on All Channels for QT Click > (between the two tables) to view measurements for All Leads for QT on the lower table. Tabular Screen The Tabular screen (see page 85) displays calculations of the QRS parameters in all the leads in a tabular format. Original calculations or changes performed in the other screens (Averages, QRS, or Caliper) are displayed in a tabular format and can be printed out. NV-54/PCECG1200W 88 Instructions for Use and Technical Description Averages Display Figure 21: MeasurementsAverages Display The Averages screen displays the average QRS in each of the leads and the average ECG of the Strip lead. Each QRS identified is marked with a red marker in the strip lead (The marker actually marks the R wave of every QRS). The QRS markers can be moved to the left and right (between the previous and the next marker). Changes in marker positions are recalculated and displayed in the tabular screen and the QRS screen. Norav Medical Ltd.

Measurements/ Interpretation 89 QRS Display Figure 22: MeasurementsQRS display The QRS screen displays the QRS in each of the leads and a strip lead of a default lead (defined in the setup of the application from which Measurements was accessed). The QRS displayed in each of the leads is marked by a red rectangle in the strip lead. To view a different QRS in all the leads, drag and drop the square by to a different QRS. The QRS markers can be moved to the left and right (between the previous and the next marker). Changes in marker positions are recalculated and displayed in the tabular screen and the Averages screen. NV-54/PCECG1200W 90 Instructions for Use and Technical Description Toolbar of Averages/QRS Displays Vertical Scale Horizontal Scale Figure 23: Toolbar of Averages/QRS Norav Medical Ltd. Measurements/ Interpretation 91 Caliper Display Figure 24: MeasurementsCaliper Toolbar of Caliper Display Print Average Grid About Wave type Add/remove marker Reset measurement Caliper Next QRS Left/up marker Remarks QRS Previous QRS Back Save Table Next strip Filters Right/down marker Marker time Figure 25: Toolbar of Caliper NV-54/PCECG1200W Instructions for Use and Technical Description The Caliper screen (above) is opened via the menu, the toolbar, or by double clicking a lead in the QRS or Averages screens. It displays one QRS with its values. The user can edit locations of wave markers, display different QRS in the same lead, or navigate through leads and display QRS in different leads. Changes in wave marker positions are recalculated and displayed in the tabular screen. Toolbar and Menus 92 To do this Save Measurements Print ECG Add/View Remarks Reset Measurements To Open Measurements in Table Format To Display QRS Averages To Display QRSs in All the Channels Display Caliper Display the Next Leads Display/Hide the Grid Click this icon Or use this short-cut key Or select this menu Description Ctrl+S File > Save Saves measurements to test file on disk. F6 File > Print ECG Off line printing. The ECG is printed in miniature format. Horizontal: 6.25 mm/sec, vertical: 2.5 mm/mV. Alt+V+R View >

Remarks Lets you enter free text during or after the ECG recording. This is printed and saved together with ECG traces. Alt+F+M File > Reset Measurements Reset measurements to those calculated by the application. This option will eliminate all the modification performed manually in the measurements. Ctrl+0 View > View Format >

Measurements table View > View Format >

Averages View > View Format >

QRS View > View Format >

Caliper View > View Format >

Next strip Displays the measurements in a table format. Displays the QRS averages on screen. Displays the QRSs in all the channels on screen . Displays the Caliper. Lets you scroll through all leads in the 3X1 display. View > Grid Optional display of 5mm raster. Norav Medical Ltd. Measurements/ Interpretation 93 Click this icon Or use this short-cut key Or select this menu Description

Help >

About View > View Format >

Previous QRS View > View Format >

Next QRS ECG >

Filters >

50/60 Hz ECG >

Filters >

EMG ECG >

Filters >

BaseLine

Displays software version number. Quote this for any software inquiry. Also shows memory size and free disk space. The HASP ID number is the ID of existing software keys. This ID number is used for adding software options. Moves to previous QRS on the same channel. Moves to next QRS on the same channel. ON/OFF for line interference filter. Set OPTIONS for 50 or 60 Hz prior to operation. ON/OFF for muscle noise filter. ON/OFF for baseline filter on ECG data. Enabled in Caliper screen when a wave type and marker name are selected. Click to move the marker right or down (according to the marker selected). Disabled when no wave marker is selected or the Caliper screen is not displayed.

(Averages and QRS screens)

Lets you choose between horizontal displays of 12.5, 25, 50, and 100 mm/sec.

(Default: 25 mm/sec)

In Caliper, lets you select the QRS wave type from the list to view its markers. After selecting the wave type, select a marker name to move it.

(Averages and QRS screens)

Lets you choose between vertical displays of 5, 10, 20, and 40 mm/mV.

(Default: 10 mm/mV) To do this To Display Information Previous QRS Next QRS Set 50/60 Hz Filter Set EMG Filter Set Base Line Filter Move Marker to Right/Bottom Horizontal Resolution Select QRS Wave Type Vertical Resolution NV-54/PCECG1200W 94 Instructions for Use and Technical Description Click this icon Or use this short-cut key Or select this menu Description To do this Select Name of QRS Marker Add/Remove ECG Wave Marker Print Reports

File >

Add/Remove ECG Wave Marker File > Print Reports In Caliper, lets you select the name of a marker to edit it (move it up/down/left/right).

(Caliper screen only) Opens a dialog box and lets you check/clear the wave markers to be displayed and calculated. Lets you choose the report to be printed from the sub-menu: Single QRS/QT Report, Multiple QRS Report, or All Reports. Table 26: Measurements Toolbar and Menus Norav Medical Ltd. DATABASE APPLICATION 95 CHAPTER 13: DATABASE APPLICATION

(This option is available with the D1\D2 license) Database application is an optional package requiring a D1 or D2 permission license. Install Database from the PC-ECG1200 package. Keep and manage ECG studies in a catalog organized according to patient name or ID. In a network, users can share the database (save it in the server). Data acquisition for all applications can be initiated either in the application itself or from the database main screen. Select group field values for query of displayed list of patients List of tests referring to selected patient (selected test highlighted) Figure 26: Database Main Screen List of patients in database (or in selected group) NV-54/PCECG1200W 96 Instructions for Use and Technical Description First Time Use When you first start Database application, you are prompted to confirm the location of the database. Choose New if no database exists Choose Open to work with an existing database Figure 27: Database Patient Query Norav Medical Ltd. DATABASE APPLICATION 97 Figure 28: Database Properties of Selected test Comparing Rest Tests Database application allows the user to compare rest tests on 1 or 12 channels. To Compare Rest Tests 1. Select two or more Rest tests from the Database interface 2. Click Compare NV-54/PCECG1200W 98 Instructions for Use and Technical Description Database Setup Click Setup on the Toolbar to access the following parameters:

Tab Description Default Workspace Choose Data Directory External Patient Data file Delete with Password Select the default workspace. Input data directory (with browsing option). Input the location of the external patient data file (with browsing option for PatientFile.INI file). Check this option to require a password for DELETE (default: unchecked). Table 27: Database Setup Options Toolbar and Menus To do this Click this icon Or use this short-

cut key Or select this menu Description Main Toolbar Connect to Database Import tests to database Define Workspace Preferences Ctrl+W File >

Database Connection Wizard Ctrl+I File > Import ECG Data File Creates a new database or retrieve path for an existing one. Adds studies recorded and saved outside the database. To select all patient data files within a directory, press CTRL + A and verify that all files are checked. Ctrl+T View > Setup Defines the location of default workspace, patient identification, and a special file called External File. This file (Windows.INI format) allows the user to prepare a list of patients that can be read by PC-ECG 1200 applications. Note: This feature does not require the D3 software key. Edit Groups File > Groups Defines different patient groups, such as Private, HMO, Military, etc. Norav Medical Ltd. DATABASE APPLICATION 99 Click this icon Or use this short-

cut key Or select this menu Description To do this View Application Information Patient Toolbar Find a Patient Open Patient Detail Add New Patient to Database Delete a Patient Perform a New Test Test Toolbar Open a Test Help > About Displays version number, communication and web information, and disk and RAM memory size. The HASP ID number is used for identification of the software key for adding software options. Patient > Find Allows the user to find a patient by entering a string in any or all of ID, Last Name, and First Name fields. Patient >

Open Patient Allows the user to check for patient information before performing a study on a patient. Patient > New Patient Inserts a new patient. You are prompted to enter partial or complete patient details. Enter ID, Last, and First Name at least. If patient details match an existing one you cannot add this patient to the list. The existing patient matching the details will be checked to allow the user to add a study. Patient >

Delete Patient Deletes an entry. If the entry is not empty of studies, you will be asked to confirm deletion. Patient > New Test Starts the application and starts recording. Test > Open Test Allows the user to view a study. You must first select a study to activate OPEN. NV-54/PCECG1200W 100 Instructions for Use and Technical Description Click this icon Or use this short-

cut key Or select this menu Description To do this Compare Rest tests Copy a Test Move a Test Delete a Test Test >

Compare Test > Copy Test Test > Move Test Test > Delete Test File > Update Database File > Print Setup Test > Test Properties Select two or more Rest tests from the Database interface and click Compare. This option is only available when you check Setup >

ECG Recording > Use ECG Database. Click Compare again to end Compare mode and display the Rest test. Copies a study. Moves a study and deletes it from the database. The default option is to leave the studys properties in the database: upon completion of the operation. The study remains in the list with an X sign. You can choose to remove the entire study instead. Deletes a study from the database. The default option is to leave the studys property in the database:

upon completion of the operation, the study remains in the list with an X sign. You can choose to delete the entire study instead. Updates the database. Opens the Print Setup dialog box to set printing preferences. Displays study properties. Update Database Print Setup View Test Properties Table 28: Database Toolbar and Menus Norav Medical Ltd. Interfacing with Information Systems 101 APPENDIX A:

INTERFACING WITH INFORMATION SYSTEMS There are several ways to exchange information between PC-ECG 1200 and Hospital Information System (HIS). These are described below:

Demographic Data Information System Prepares Patient Demographic Data for PC-ECG 1200:

This uses a text file called PatientFile.ini. The location is defined in Database setup. File Name: PatientFile.ini File Format:

[PATIENTDATAXXX]

ID=

LastName=

FirstName=

BirthDay=

BirthMonth=

BirthYear=

Sex=

Weight=

Height=

Address=

Phone1=

Phone2=

Fax=

E-Mail=

Medications=

Other=

[PatientDataXXX]Section name. XXXnumber from 000 to 200. At least one of the keys ID, LastName, or FirstName must be completed. If all these keys are empty, section of this patient will be ignored. The keys Height, Address, Phone1, Phone2, Fax, Email, Medications and Other appear only with Database. NV-54/PCECG1200W 102 Instructions for Use and Technical Description Example:

[PatientData001]

ID=1234567890 LastName=Smith FirstName=Worker BirthDay=11 BirthMonth=6 BirthYear=1959 Sex=1 Weight=59 Height=170 Address=523 Main st. Tacoma Mexico Phone1=702-8765643 Phone2=702-8743031 Fax=702-8743032 E-Mail=nkir@sympo.ca Medications=none Other=none

[PatientData003]

ID=123456789 LastName=Smith FirstName=Worker3 Norav Medical Ltd. Interfacing with Information Systems 103 HL7 Format File PC-ECG Prepares HL7 Format File with Stress Test Results This file is created upon demand in the study review screen. The file of Stress test in Format HL7 includes:

1. Patient Information:

Name:

Last Name:

Id Number:

Birth Date:

Sex:

Weight:

John Smith 12345678 24/1/1955 M 80 kg 2. Hospital and Physician Information:

Hospital Name:

General Hospital Hospital Address: Megapolis Physician Name: Dr. Stern 3. Test Date and Time:

Test Date:

Test Time:

18/09/1999 12:41:51 4. Test Results:

Protocol:

Target HR:

Max HR:

Max. SBP:

Max. DBP:

Max. METS:

Max. VO2:

ST =

Bruce 183 175 (95%) 200 100 8.8 30.9 J+60 NV-54/PCECG1200W 104 Instructions for Use and Technical Description 5. Results of Blood Pressure, HR, Double Product (HRXBP sys.), ST level (mm) and ST Slope (mV/sec) for the Most Important Stages of Stress Test:

Rest: BP: 150/100, HR: 79, Product: 11850, ST Level (mm), Slope (mV/sec) (-

1.2/0.7, 0.2/1.8, 1.9/-0.5, -2.0/0.4, -2.9/3.3, -1.1/2.6, -1.4/2.2, -1.6/1.8, -1.3/6.1,

-1.8/2.5, -1.7/1.5) Max HR: Time: 7:05, BP: 200/100, HR: 175, Product: 35000, ST Level (mm), Slope (mV/sec) (-1.2/0.7, 0.2/1.5, 1.9/-0.5, -2.0/01, -2.9/3.3, -2.1/2.6, -1.4/2.2, -

1.4/1.8, -1.7/6.1, -1.2/2.4, -1.7/1.5) Worst ST: Lead aVF:-1.2 mm, Time:4:15, BP:200/100, HR:137, Product: 27400, ST Level (mm), Slope (mV/sec) (-1.3/0.4, 0.2/1.5, 1.2/-0.5, -2.0/01, -2.5/3.3, -

2.1/2.6, -1.7/2.2, -1.4/1.8, -1.3/2.1, -1.2/2.4, -1.7/1.5) Recovery: Time: 10:59, BP: 170/80, HR: 127, Product: 21590, ST Level (mm), Slope

(mV/sec) (-1.3/0.4, 0.6/1.5, 1.3/-0.5, -2.0/01, -1.5/3.3, -2.1/2.6, -1.5/2.2, -

1.4/1.9, -1.3/2.1, -1.2/2.3, -1.7/1.5) 6. Physician Remarks and Conclusions:

Reason for Test:

Chest pressure Reason for Ending Test:

Fatigue Conclusions:

Normal blood pressure Norav Medical Ltd. Interfacing with Information Systems 105 GDT/BDT Type Communication PC-ECG and HIS (Hospital Information System) Maintain Bi-Directional GDT/BDT Type Communication 1. In setup, select GDT/BDT. Import demographic data from HIS to PC-ECG a. b. Check Import from GDT/BDT. c. Define the GDT/BDT directory (in which the HIS file will be ready). d. Define the first four characters of the Token for PC-ECG file. This file always contains the last patient data. 2. Export the GDT/BDT file from PC-ECG to HIS. In setup, select GDT/BDT. a. b. Check Save Test in GDT/BDT. c. Define the GDT/BDT directory (in which PC-ECG file will be ready). It can be the same as in 1. d. Define the first four characters of the Token for Practice EDP file. This file always contains the last patient data. NV-54/PCECG1200W 106 Instructions for Use and Technical Description Saving the Stress Test as a RAW Data (native binary) Format File 1. Record a stress study 2. Under File menu, create a RAW Data File. A file with extension RDT is created, with the following structure:

(low byte, high byte) x 12 Leads x n samples (1sec = 500 samples). Leads sentence - I, II, III, AVR, AVL, AVF, V1, V2, V3, V4, V5, V6. Byte Number Byte Type Lead Number Sample Number Second Number 1 2 3 4 21 22 23 24 25 26 27 28 45 46 47 48 1+(n-1)*24 2+(n-1)*24 3+(n-1)*24 4+(n-1)*24 21+(n-1)*24 22+(n-1)*24 23+(n-1)*24 n * 24 Lb Hb Lb Hb Lb Hb Lb Hb Lb Hb Lb Hb Lb Hb Lb Hb Lb Hb Lb Hb Lb Hb Lb Hb I II V5 V6 I II V5 V6 I II V5 V6 1 2 1 n n/500 Table 29: Stress Raw Data File Format Norav Medical Ltd. Interfacing with Information Systems 107 Saving the Monitor Test as a Raw Data (Native Binary) Format File 1. Record a Monitor study. 2. Under File menu, create a RAW Data File. A file with extension RDT is created, with the following structure:

Number Leads (low byte, high byte) + Sample Rate (low byte, high byte) + (low byte, high byte) x Number Leads x n samples (1sec =

(sample rate)). Byte Number Byte Type Lead Number Sample Number Second Number 1 2 3 4 2N -1 2N 2N +1 2N +2 2N +3 2N +4 2N*2-1 2N*2 1+(n-1)*2N 2+(n-1)*2N 3+(n-1)*2N 4+(n-1)*2N 2N*n-1 2N*n Lb Hb Lb Hb Lb Hb Lb Hb Lb Hb Lb Hb Lb Hb Lb Hb Lb Hb 1 2 N 1 2 N 1 2 N 1 2 1 n n/

(sample rate) Table 30: Monitor Raw Data file format NV-54/PCECG1200W 108 Instructions for Use and Technical Description APPENDIX B:

TECHNICAL SPECIFICATIONS 1200W (Transmitter) ECG Patient Leads Lead Standards Defibrillator Protection:

Patient Leakage current Input Impedance CMRR DC max. input Frequency Range (-3db) Signal dynamic range Battery Operation Time A2D A2D resolution Full scale range LSB weight Full scale +

Midscal Midscale LSB Full scale -

Sample Rate Communication Frequency Range Output Power Mechanical Weight [g]

Size [mm]

Environmental Operating Temperature Range Storage Temperature Range:

Relative Humidity Regulatory Safety Standards Device Classification Detachable 10 lead wires conform to AAMI AHA or IEC Protected against 360 J discharge

<10 A

>100 Mohm

>100 db

+/- 300 mv 0.05 150 Hz 20 mV 4 - AA alkaline or NIMH rechargeable Up to 40 hours with 4 AA alkaline battery 16 bit, 2 complement

+/- 10 mV 0.3 V

+10 mV (Digital value = 7FFF hex ) 0 mV (Digital value = 0000 hex )

-0.3 V (Digital value = FFFF hex )

-10 mV (Digital value = 8000 hex ) 500 2400-2483.5 Mhz 0.4mW, conform to FCC part 15.249 350 160x100x45 0C to 50C

-40C to 70C 0-85% non-condensing IEC60601-1; IEC60601-2-25; IEC60601-2-

27; IEC60601-2-51; EN301 489-1; EN301 489-3; EN300 440 Type CF, battery operated Norav Medical Ltd. Technical Specifications 109 NV-54/PCECG1200W 110 Instructions for Use and Technical Description 1200WR (Receiver) Communication Frequency Range Output Power 2400-2483.5 Mhz 0.4mW, conform to FCC part 15.249 USB 2.0 compliant, Full Speed Device Control, Isochronous Transfer Types Power In Mechanical Weight[g]

Size [mm]

Environmental Operating Temperature Range Storage Temperature Range:

5v, 40mA 50 103x30x30 0C to 50C

-40C to 70C Relative Humidity 0-85% non-condensing Norav Medical Ltd. APPENDIX C: REPORT SAMPLES Report Samples 111 Figure 29: Rest Report NV-54/PCECG1200W 112 Instructions for Use and Technical Description Figure 30: Stress Applications - Comprehensive Report Norav Medical Ltd. Report Samples 113 Figure 31: ECG Monitoring Report NV-54/PCECG1200W 114 Instructions for Use and Technical Description Figure 32: Heart Rate Variability Report Norav Medical Ltd. Report Samples 115 Figure 33: Late Potential Report NV-54/PCECG1200W 116 Instructions for Use and Technical Description APPENDIX D:

TROUBLESHOOTING USB Driver is not Installed Properly on Windows XP During PC-ECG Installation Problem If you connect the device to the PC via the USB before installing PC-ECG 1200

(including the USB driver), the USB driver is not installed. The Windows operating system identifies new hardware and starts the hardware installation wizard. If you complete the wizard, the driver is not found and the hardware is defined in the Device Manager as USB device with an icon ? indicating that the driver is not correctly installed. If the USB cable is left connected while trying to install the driver from the PC-

ECG1200 installation CDa message regarding Win XP signature does not appear and the driver is not installed. Solution 1. Disconnect the USB cable. 2. Install the PCECG software from the CD-ROM. During installation a message should appear about the Windows XP signature. If the message does not appear during the installation of PC-

ECG, then the driver is not installed. If working under Windows XP press Continue anyway on message regarding the digital signature. 3. Check if the driver is now installed correctly (there is no question mark icon next to the USB driver in the device manager and the LED on the USB adaptor is on). If the device is still not correctly installed, then complete the following steps:

4. uninstall the unidentified USB driver as follows:

a. While still connected to the USB, right click My Computer. b. Select Properties from the pop-up menu. c. Click Device Manager on the Hardware tab. d. Double click the USB Device with the ? icon in the list of devices. e. Select Driver tab. f. Click Uninstall and then OK. 5. After the driver is deleted, disconnect the USB cable from the PC. 6. Install the PC-ECG software and continue to the next step. 7. Reconnect the USB cable to the computer connector. Windows XP identifies the new hardware automatically and the new hardware wizard opens. 8. Follow the instructions on screen. If working under Windows XP press Continue anyway on message regarding the digital signature. After the driver is installed make sure the green light is illuminated on the 1200 USB adaptor Norav Medical Ltd. Troubleshooting 117 Recovering ECG Data after Unexpected Shutdown of the Stress Application Problem If the application terminates unexpectedly before the ECG test is completed and saved, it may be possible to recover the ECG data of the (exhausted [??]) patient. Solution Stress ECG application stores native ECG data in the temporary file. You can convert this data into Monitoring ECG application file format as follows:

1. Start the Stress ECG application. 2. Click Recovery File to Monitoring Format in the File main menu. The Choose files for conversion dialog box is displayed. 3. Select the Windows\Temp folder. 4. Select strXX.tmp last created temporary file and click Open. 5. Select the Monitoring ECG files folder. 6. Insert monitoring ECG file name according to patient ID or last name and click Save. 7. Close the Stress ECG application. 8. Open the Monitoring ECG files folder and double click on the last stored file. The monitoring ECG application opens. 9. Click the Patient main menu button and insert patient data. 10. Save the updated Monitoring ECG file. You can now inspect and print ECG strip from the Monitoring ECG application. Working in AutoSave Mode Without Saving Modifications If you perform modifications (adds/edit remarks, measurements, recalculations, etc) while in AutoSave mode, but do not wish to save the modifications, do the following:

1. Click Setup. 2. Uncheck the Auto Save option and click OK. 3. Close the application (or the file) with the X button. A dialog box is displayed requesting acknowledgement for the save. 4. Click No. 5. Reopen the application and the file. 6. Check that the modifications were not saved. 7. It is now safe to re-enable the Auto Save mode (if required). NV-54/PCECG1200W 118 Instructions for Use and Technical Description A Thick Straight Line is Displayed For All Leads Problem A thick straight line appears on screen for all leads when the connection to the acquisition box fails. Solution When using USB connection, check that the led on the 1200USB adapter is illuminated. If the led on USB adapter is not illuminated, check connections to the USB port and to the adapter. If the led on the USB adapter is illuminated or if connected through RS232, check the connection to the acquisition box and make sure the box is switched on. Noisy ECG Signal on Leads Problem A noisy ECG signal on one or more of the leads may be caused due to poor connection of the appropriate electrodes or leads on the patient. Solution Check the connection of the appropriate leads on the patient Make sure the electrodes are applied OK on the patient. Norav Medical Ltd. Troubleshooting 119 Missing data after a thick line Problem On the screen and in printouts of the ECG, appears for a few seconds a thick strait line and after that there is missing data for a period of time. The ECG traces resume after this random period of time. This problem may be caused due sleep mode or hibernation mode the PC entered while the ECG test was running. Solution Any settings related to the power management should be disabled: no standby, no stop HD, no hibernation, etc... on the laptop during the Stress test. To set the power management do the following:

1. right click on the desktop. 2. select PROPERTIES form the pop-up menu. 3. Select SCREENSAVER tab. 4. Press on POWER button in the Monitor Power frame. 5. Select Power Schemes as either PRESENTATION or HOME\OFFICE DESK. 6. Set NEVER to "Turn off Hard Disk", "System Standby" and

"System Hibernates". 7. Press OK to apply this configuration. NV-54/PCECG1200W